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Specially Trained Registered Nurses Can Safely Manage Epidural Analgesia Infusion in Laboring Patients
Specially Trained Registered Nurses Can Safely Manage Epidural Analgesia Infusion in Laboring Patients Lenore A. Charles, DNP, CNM, Elise Korejwa, MS, Donna Curtis Kent, MS, RN, Debbie Raniero, MBA, RN Purpose: To discover evidence for defining the registered nurse’s (RN’s)
role in the management of epidural analgesia in the labor and delivery setting. Design: The Labor Epidural Nurse Safety (LENS) study consisted of two parts. The first part was a 10-year retrospective review of the outcomes of 2,568 laboring women for whom epidural catheters had been placed and verified by an anesthesiologist or certified registered nurse anesthetist, then continuous epidural infusion initiated, and basal rate or patient-controlled epidural analgesia (PCEA) dose increased, if needed, within specified parameters by specially trained labor and delivery RNs. The second part compared the outcomes of the neonates born to the 2,568 women in the first part of the study with neonates born to mothers who received PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists and/or certified registered nurse anesthetists at two control sites. Methods: Maternal outcomes were quantified by incidences of clinically significant hypotension and sentinel events, such as respiratory distress, cardio/respiratory distress, loss of consciousness, and seizures. Evidence of neonatal outcomes was collected by comparing Apgar scores. Findings: No sentinel events occurred, and there was no increase in maternal hypotensive events in the RN-managed group. There were no statistically significant differences in Apgar scores between the experimental and control groups. Conclusion: Specially trained RNs can safely initiate continuous infusions and increase the basal rate of epidural analgesia infusions or PCEA doses administered to laboring women, after insertion and confirmation of correct catheter placement by a qualified anesthesia provider, without adversely affecting maternal and fetal/neonatal outcomes. Keywords: labor, epidural, analgesia, nurse, manage. Ó 2015 by American Society of PeriAnesthesia Nurses
Lenore A. Charles, DNP, CNM, is a Nurse Midwife at Bella Vie Birth Center, Salem, OR; Elise Korejwa, MS, is a student at Oregon State University, Corvallis, OR; Donna Curtis Kent, MS, RN, is a Nurse Educator at AnMed Health, Anderson, SC; and Debbie Raniero, MBA, RN, is the Nurse Manager of Labor and Delivery at St. Joseph’s Medical Center, Tacoma, WA. Conflict of interest: None to report.
Journal of PeriAnesthesia Nursing, Vol 30, No 3 (June), 2015: pp 209-214
Address correspondence to Lenore A. Charles, PO Box 126, Dayton, OR 97114; e-mail address: lenorecharles@hotmail. com. Ó 2015 by American Society of PeriAnesthesia Nurses 1089-9472/$36.00 http://dx.doi.org/10.1016/j.jopan.2015.01.008
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THE FIRST USE of epidural analgesia in obstetrics was reported by Graffagnino and Seyler in 1938.1 Since then, epidural analgesia has been used with increasing frequency to manage pain during labor and delivery.2,3 With the widespread use of epidural analgesia came the need to define the role of the registered nurse (RN) in the management of this therapy. Both anesthesia and nursing organizations have published position statements based on expert opinions as evidencebased data are lacking.4–10 Defining the RN’s role in the management of labor epidural analgesia is a critical undertaking because a challenge in supply and demand of this method of pain control in small hospitals has occurred at a national level. The most recent Obstetric Anesthesia Workforce survey found that only 3% of small hospitals (100 to 500 births annually) provided in-house anesthesia coverage, and mid-sized hospitals (500 to 1,499 births annually) had experienced a decrease in in-house anesthesia coverage.3 Often, interventional anesthesia management in the community setting has been limited, for example, to one-shot spinal analgesia.3 At the same time, demand for labor epidural analgesia has increased; in 2008, 61% of laboring women in a 27-state reporting area received epidural analgesia, and the number of women who desire epidural analgesia continues to rise.2 On a national level, controversy surrounding the RN’s active role in the management of epidural analgesia in laboring patients was growing in the early 2000s.5,6 Some experts asserted that RNs should not perform activities such as initiation and rate adjustments of established continuous epidural analgesia infusions in laboring patients.7,10 Other experts supported the RN’s role in the management of pain relief during labor, including initiating continuous infusions and increasing the rate of epidural analgesia infusions administered to laboring women after insertion and confirmation of correct epidural catheter placement by a qualified anesthesiologist or certified registered nurse anesthetist (CRNA).4,9,11 Obstetric anesthesia experts underscored the belief that women requesting epidural analgesia during labor should not be deprived of the therapy based on lack of anesthesiologist coverage and proposed solutions.9 Boards of nursing in several states had begun to exclude nurses in labor and delivery from perform-
ing these tasks, and many hospitals restricted the role of the RN in the management of epidural analgesia in laboring patients.3 These constraints in RN practice in the management of labor pain occurred at the same time that RNs and nurse midwives in other countries, such as the United Kingdom and Australia, were establishing an abundant experience of safely performing the same tasks with epidural infusions in laboring patients.12–14 The impact of this RN role restriction on the availability of epidural analgesia for women who desire the therapy is unknown, but nonetheless concerning.3 The Labor Epidural Nurse Safety (LENS) study was undertaken to determine if specially trained RNs could initiate and increase the rate of labor epidural analgesia continuous infusions without adversely affecting maternal and fetal/neonatal outcomes. The overarching goals of the LENS study are to expand the RN’s role in the management of labor pain and help bridge the gap between anesthesia providers and their patients who receive epidural analgesia during labor.
Literature Review The literature was searched from 2000 to 2013 in MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Health Source: Academic Edition, PubMed, and Cochrane Database of Systematic Reviews. Although no research that addressed the RN’s role in the labor epidural infusions in the United States was found, a substantial body of literature demonstrating the safety and efficacy of continuous epidural infusions and patient-controlled epidural analgesia (PCEA) during labor was identified and reviewed.15–27 PCEA allows patients to manage their own pain by pressing a button on an infusion device to deliver a dose of analgesic; it has been shown to be a highly effective mode of labor pain management.28 The prevalence of patients safely and effectively managing their own labor pain, according to their individual needs, underscores the appropriateness of specially trained RNs being able to perform similar functions.4,11
Research Methods The LENS study consisted of two parts. The first part was a 10-year retrospective medical records review of the outcomes of 2,568 laboring women for whom epidural catheters had been placed and
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Table 1. Registered Nurse (RN) Training Requirements 1. The RN will a. Attend mandatory educational lectures related to epidural analgesia in the laboring patient i. Achieve a passing score on written examination b. Attend mandatory skill demonstration and return-demonstration sessions i. Demonstrate to an anesthesia provider or a senior RN the proper technique for all skills related to epidural analgesia in the laboring patient 2. After completion of the above requirements, the RN will be able to a. Demonstrate an understanding of hospital policy and procedure regarding the administration and management of epidural analgesia in the laboring patient b. Demonstrate the acquired knowledge of anatomy, physiology, pharmacology, side effects, and complications related to the analgesia technique and medications being administered to the laboring patient c. Assess the laboring patient’s total care needs (physiologic and emotional) while receiving epidural analgesia d. Use monitoring modalities, interpret physiologic responses, and initiate nursing interventions to ensure optimal patient care during epidural analgesia in the laboring patient e. Anticipate and recognize potential complications of epidural analgesia in the laboring patient with regard to the epidural catheter, infusion device, and medications being used f. Recognize emergency situations and institute nursing interventions in compliance with established institution policies, procedures, guidelines, and anesthesia provider’s orders g. Demonstrate the cognitive and psychomotor skills necessary for use and removal of the epidural catheter and infusion device h. Demonstrate knowledge of the legal ramifications of the management and monitoring of epidural analgesia in the laboring patient, including the RN’s responsibility and liability in the event of untoward reactions or lifethreatening complications i. Identify patient/family educational needs and limitations and provide the patient/family with information/education regarding epidural analgesia and the infusion device i. Contact anesthesia provider as needed for provision of medical information 3. The RN will participate in mandatory annual competency review, including demonstrating correct skill technique and achieving a passing score on an annual written examination Data from Pasero C, Eksterowicz N, Primeau M, Cowley C. Registered nurse management and monitoring of analgesia by catheter techniques: Position statement. Pain Manag Nurs. 2007;8:48–54.
verified by an anesthesiologist or CRNA, then continuous epidural infusion initiated, and basal rate or PCEA dose increased, if needed, within specified parameters by specially trained labor and delivery RNs (see Table 1 for RN training requirements). After considering the results of the first part of the study, the primary author received approval to undertake a second part with the goal of comparing the outcomes of the neonates born to the 2,568 women in the first part of the study with neonates born to mothers who received PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists and/or CRNAs at two control sites. The second part of the study evaluated only neonatal outcome data because maternal outcome data were not available for analysis at the two control sites. Internal Review Board (IRB) approval was obtained at the experimental and control sites
before conducting the data collections; none of the IRBs required patient consent. The first part of the LENS study was conducted at the Bay Area Hospital in Coos Bay, Oregon. Maternal outcomes were measured as the incidences of clinically significant hypotension and sentinel events, such as respiratory distress, cardio/respiratory distress, loss of consciousness, and seizures associated with the administration of epidural analgesia during labor. Hypotension was defined as a systolic blood pressure (BP) less than 90 mm Hg requiring the administration of ephedrine per hospital protocol. Hypotensive episodes that occurred within 20 minutes of the RN’s initiation or rate increase of a continuous epidural infusion were considered the result of the RN’s action. A 20-minute interval was selected in accordance to parameters set by
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the anesthesia department, which required close patient monitoring for 20 minutes following initiation of continuous epidural infusion or adjustment of basal rate or PCEA dose. Hypotensive events were identified by reviewing pharmacy accounting records of ephedrine used from 2001 through 2010, and then the medical records of all patients who had received ephedrine for the treatment of hypotension during that time were reviewed. All Unusual Occurrence Reports (the hospital’s method of tracking errors and unexpected outcomes) submitted from 2001 through 2010 for obstetrical analgesia and/or anesthesia were also retrieved and reviewed to identify sentinel events that occurred during the study time frame. Once identified, the medical records of these patients were reviewed, and the details of the events verified. The Bay Area Hospital served as the experimental site for the second part of the study, which evaluated neonatal outcome (Apgar scores). Two other hospitals, AnMed Health in Anderson, South Carolina and St. Joseph’s Medical Center in Tacoma, Washington, were recruited to serve as control sites. The control sites provided PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists or CRNAs. The Apgar scores of the 2,568 newborns born of women who received continuous epidural infusion by specially trained labor and delivery RNs at the experimental site, as described previously, were compared with the Apgar scores of 3,394 newborns at the two control sites combined. The Apgar scores, along with use of oxytocin, misoprostol, or dinoprostone (as possible confounding variables), were collected from the Delivery Log books from all the three sites.
Population and Protocol Of the 6,176 women who delivered at Bay Area Hospital during the 10-year review period, 2,568 delivered vaginally, had epidural analgesia, and received care from specially trained RNs. The only women excluded from participating in the first part of the study were those who had experienced a previously diagnosed intrauterine fetal demise. After placement of the epidural catheter and test dose by an anesthesiologist or CRNA, the specially trained RNs initiated the continuous infusions and increased the basal rate of epidural analgesia infu-
sions, if needed, by 2 mL/hour one time or increased PCEA doses by 2 mL one time. According to standing orders, RNs were required to immediately notify an anesthesiologist or CRNA for any decrease in systolic BP to 90 mm Hg or lower, insufficient pain relief after one increase in basal rate or PCEA dose, respirations , 8 breaths/minute, any other emergency, or any questions or difficulty with pain management. The maternal outcomes of the RN-managed group were evaluated for the first part of the study, and the Apgar scores of the infants of these 2,568 women were collected and compared with those at two control sites to evaluate neonatal outcome for the second part of the study.
Results First Part In the patients who received RN-managed labor epidural analgesia during the 10-year span of the first part of the study, 12 clinically significant hypotensive episodes (decrease in systolic BP to 90 mm Hg or lower) occurred without identifiable associations; one clinically significant hypotensive episode occurred within 20 minutes after a RN intervention, and no sentinel events occurred. Two cases of maternal respiratory distress occurred and were deemed to be unassociated with RN interventions (each of these occurred immediately after an anesthesiologist’s administration of fentanyl and bupivacaine via direct epidural bolus). Second Part The findings in the second part of the study contain an interesting statistical twist, in that most controlled trials attempt to prove that a particular variable causes a change, whereas our hypothesis was that the independent variable would not make a difference. Our interest in the null hypothesis presented the interesting twist because one cannot prove the null.11–14 Independent variable: Specially trained RNs initiating and adjusting continuous epidural analgesia infusions. Null hypothesis: Specially trained RNs initiating and adjusting continuous epidural analgesia infusions will not make a
EPIDURAL ANALGESIA INFUSION IN LABORING PATIENTS
difference in maternal/fetal/neonatal outcomes. Conventional hypothesis (which would attempt to disprove the null hypothesis): Specially trained RNs initiating and adjusting continuous epidural analgesia infusions will adversely affect maternal/fetal/neonatal outcomes.
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the past several years. This research also suggests that a specially trained RN staff can help to bridge the gap between anesthesia providers and their laboring patients who receive epidural analgesia, perhaps increasing the availability of epidural analgesia during labor as a pain relief option for more women.
Limitations Descriptive statistics of the Apgar scores at the three sites were similar. The experimental site had lower mean Apgar scores than one of the controls but higher than the other; however, the differences were insignificant. Nonparametric, bootstrapped quantile regression on the median detected no differences between the experimental and the control groups (95% confidence interval, [0,0] for all comparisons). The ordinary least squares regression was statistically significant, but the direction of the effect was inconsistent. Some comparisons showed the experimental site outperforming the control sites and some comparisons showed the reverse. This statistical significance is a result of the very large sample size. The actual effect size is very small, ranging from 0.01 to 0.05 of an Apgar score, and the confidence intervals are within the range of clinical insignificance, which we defined as half of an Apgar score. These results point to evidence in favor of the null hypothesis, that is, the difference in the mean Apgar scores was zero after controlling for the potential confounding variables. There was no evidence that babies born at the hospital where specially trained RNs managed epidural analgesia had a higher risk of a low Apgar score compared with the two hospitals where anesthesia providers managed epidural analgesia.
Discussion and Implications The fact that neither laboring women nor their fetuses/newborns were adversely affected when specially trained RNs initiated and increased the rate of their continuous epidural analgesia infusions during labor has important implications for clinical practice. The data indicate that, with proper initial and ongoing training, RNs in the labor and delivery setting are capable of assuming a role similar to what RNs in other care settings have assumed over
There were limitations to the LENS study that must be considered when interpreting the findings. The scope of this study was restricted by its retrospective nature, making the data subject to more confounding factors. Multicenter prospective studies with larger sample sizes are needed to draw more generalized conclusions. It would have been informative to compare maternal outcomes between the experimental and the two control sites in a similar fashion as the Apgar scores were compared; this is being considered for future reporting. A limitation of the second part of the study was that the Delivery Log content of demographics, history, and medical interventions was not consistent between sites; thus, many of these details could not be included in the second part of the study. Another limitation that could not be controlled was the influence of each institution’s culture surrounding the estimation of Apgar scores. The Apgar score assignment process is described as an objective measure of the newborn’s physical status; however, there is always a degree of subjective interpretation of the score parameters. Apgar scores given to a single infant often vary among the personnel making the assignment. Furthermore, the use of Apgar scores as an outcome criterion provides a vital but limited view of infant well-being.
Conclusion Our findings support the hypothesis that specially trained RNs can safely initiate continuous infusions and increase the basal rate of epidural analgesia infusions or PCEA doses administered to laboring women, after insertion and confirmation of correct catheter placement by a qualified anesthesia provider, without adversely affecting maternal and fetal/neonatal outcomes. More well-
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designed research on the RN’s role in the management of labor epidural analgesia is encouraged. The purpose of the LENS study was to establish the safety of RN initiation and rate increases of continuous epidural analgesia in laboring patients;
future research should evaluate the safety of RN administration of supplemental bolus doses as well in this population. It would also be informative to investigate maternal satisfaction with these nursing practices.
References 1. Graffagnino P, Seyler LW. Epidural anesthesia in obstetrics. Am J Obstet Gynecol. 1938;35:597. 2. Osterman MJ, Martin JA. Epidural and spinal anesthesia use during labor: 27-state reporting area, 2008. Natl Vital Stat Rep. 2011;59:1-13. 3. Bucklin BA, Hawkins JL, Anderson JR. Obstetric anesthesia workforce survey: Twenty-year survey. Anesthesiology. 2006;103:645-653. 4. Pasero C, Eksterowicz N, Primeau M, et al. Registered nurse management of analgesia by catheter techniques: Position statement. Pain Manag Nurs. 2007;8:48-54. 5. McMichael JP. Should nurses manage epidural or intrathecal analgesia/anesthesia by rebolusing or adjusting dosages of continuous infusions during labor and birth? Writing for the pro position. MCN Am J Matern Child Nurs. 2001;26: 234-236. 6. Poole J. Should nurses manage epidural or intrathecal analgesia/anesthesia by rebolusing or adjusting dosages of continuous infusions during labor and birth? Writing for the con position. MCN Am J Matern Child Nurs. 2001;26:234-236. 7. Association of Women’s Health, Obstetric and Neonatal Nurses. Role of the registered nurse in the care of the pregnant woman receiving analgesia and anesthesia by catheter techniques. J Obstet Gynecol Neonatal Nurs. 2012;41:456-457. 8. American College of Obstetricians and Gynecologists. Pain relief during labor. ACOG Committee Opinion on Obstetric Practice No 295. Obstet Gynecol. 2004;104:213. 9. Glazer BM, Arkoosh VA. Response to AWHONN guidelines. Society for Obstetric Anesthesia and Perinatology (SOAP) Fall Newsletter. 2002:30–32 10. Poole J. Letters to the editor. Pain Manag Nurs. 2008;9: 46-47. 11. Pasero C, Eksterowicz N, Primeau M, et al. Letter to the editor. Pain Manag Nurs. 2008;9:46-47. 12. Collis RE, Plaat FS, Morgan BM. Comparison of midwife top-ups, continuous infusion and patient-controlled epidural analgesia for maintaining mobility after a low-dose combined spinal-epidural. Br J Anaesth. 1999;82:233-236. 13. McGrady E, Litchfield K. Epidural analgesia in labour. CEACCP. 2004;4:114-117. 14. Malhotra S, Yentis SM. Extending low-dose epidural analgesia in labour for emergency Caesarean section—a comparison of levobupivacaine with or without fentanyl. Anaesthesia. 2007;62:667-671. 15. Bernard JM, Le Roux D, Vizquel L, et al. Patient-controlled epidural analgesia during labor: The effects of the increase in bolus and lockout interval. Anesth Analg. 2000;90:1085-1090.
16. Capogna G, Camorcia M, Stirparo S, et al. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: The effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011;113:826-831. 17. Chen SH, Liou SC, Hung CT, et al. Comparison of patientcontrolled epidural analgesia and continuous epidural infusion for labor analgesia. Chang Gung Med J. 2006;29:576-582. 18. Eriksson SL, Gentele C, Olopsson CH. PCEA compared to continuous epidural infusion in an ultra-low-dose regimen for labor pain relief: A randomized study. Acta Anaesthesiol Scand. 2003;47:1085-1090. 19. Halpern SH. Patient-controlled analgesia for labor. Anesth Analg. 2009;108:921-929. 20. Haydon M, Larson D, Reed E, et al. Obstetric outcomes and maternal satisfaction in nulliparous women using patientcontrolled epidural analgesia. Am J Obstet Gynecol. 2011;205: 271e1-6. 21. Leo S, Sia AT. Maintaining labor epidural analgesia: What is the best option? Curr Opin Anaesthesiol. 2008;21: 263-269. 22. Lim Y, Sia AT, Ocampo CE. Comparison of computer integrated patient controlled epidural analgesia vs. conventional patient controlled epidural analgesia for pain relief in labour. Anaesthesia. 2006;61:339-344. 23. Lim Y, Ocampo CE, Supandji M, et al. A randomized controlled trial of three patient-controlled epidural analgesia regimens for labor. Anesth Analg. 2008;107:1968-1972. 24. Sezer OA, Gunaydin B. Efficacy of patient-controlled epidural analgesia after initiation with epidural or combined spinal-epidural anesthesia. Int J Obstet Anesth. 2007;16: 226-230. 25. Valleho MC, Ramesh V, Phelps AL, et al. Epidural labor analgesia: Continuous infusion versus patient-controlled epidural analgesia with background infusion versus without a background infusion. J Pain. 2007;8:970-975. 26. Van der Vyver M, Halpern S, Joseph G. Patient-controlled epidural analgesia versus continuous infusion for labor analgesia: A meta-analysis. Br J Anaesth. 2002;89:459-465. 27. Wong CA, Ratliff JT, Sullivan JT, et al. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006; 102:904-909. 28. Pasero C, Quinn TE, Portenoy RK, et al. Opioid analgesics. In: Pasero C, McCaffery M, eds. Pain Assessment and Pharmacologic Management. St. Lousis: Mosby Elsevier; 2011: 277-622.
role in the management of epidural analgesia in the labor and delivery setting. Design: The Labor Epidural Nurse Safety (LENS) study consisted of two parts. The first part was a 10-year retrospective review of the outcomes of 2,568 laboring women for whom epidural catheters had been placed and verified by an anesthesiologist or certified registered nurse anesthetist, then continuous epidural infusion initiated, and basal rate or patient-controlled epidural analgesia (PCEA) dose increased, if needed, within specified parameters by specially trained labor and delivery RNs. The second part compared the outcomes of the neonates born to the 2,568 women in the first part of the study with neonates born to mothers who received PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists and/or certified registered nurse anesthetists at two control sites. Methods: Maternal outcomes were quantified by incidences of clinically significant hypotension and sentinel events, such as respiratory distress, cardio/respiratory distress, loss of consciousness, and seizures. Evidence of neonatal outcomes was collected by comparing Apgar scores. Findings: No sentinel events occurred, and there was no increase in maternal hypotensive events in the RN-managed group. There were no statistically significant differences in Apgar scores between the experimental and control groups. Conclusion: Specially trained RNs can safely initiate continuous infusions and increase the basal rate of epidural analgesia infusions or PCEA doses administered to laboring women, after insertion and confirmation of correct catheter placement by a qualified anesthesia provider, without adversely affecting maternal and fetal/neonatal outcomes. Keywords: labor, epidural, analgesia, nurse, manage. Ó 2015 by American Society of PeriAnesthesia Nurses
Lenore A. Charles, DNP, CNM, is a Nurse Midwife at Bella Vie Birth Center, Salem, OR; Elise Korejwa, MS, is a student at Oregon State University, Corvallis, OR; Donna Curtis Kent, MS, RN, is a Nurse Educator at AnMed Health, Anderson, SC; and Debbie Raniero, MBA, RN, is the Nurse Manager of Labor and Delivery at St. Joseph’s Medical Center, Tacoma, WA. Conflict of interest: None to report.
Journal of PeriAnesthesia Nursing, Vol 30, No 3 (June), 2015: pp 209-214
Address correspondence to Lenore A. Charles, PO Box 126, Dayton, OR 97114; e-mail address: lenorecharles@hotmail. com. Ó 2015 by American Society of PeriAnesthesia Nurses 1089-9472/$36.00 http://dx.doi.org/10.1016/j.jopan.2015.01.008
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THE FIRST USE of epidural analgesia in obstetrics was reported by Graffagnino and Seyler in 1938.1 Since then, epidural analgesia has been used with increasing frequency to manage pain during labor and delivery.2,3 With the widespread use of epidural analgesia came the need to define the role of the registered nurse (RN) in the management of this therapy. Both anesthesia and nursing organizations have published position statements based on expert opinions as evidencebased data are lacking.4–10 Defining the RN’s role in the management of labor epidural analgesia is a critical undertaking because a challenge in supply and demand of this method of pain control in small hospitals has occurred at a national level. The most recent Obstetric Anesthesia Workforce survey found that only 3% of small hospitals (100 to 500 births annually) provided in-house anesthesia coverage, and mid-sized hospitals (500 to 1,499 births annually) had experienced a decrease in in-house anesthesia coverage.3 Often, interventional anesthesia management in the community setting has been limited, for example, to one-shot spinal analgesia.3 At the same time, demand for labor epidural analgesia has increased; in 2008, 61% of laboring women in a 27-state reporting area received epidural analgesia, and the number of women who desire epidural analgesia continues to rise.2 On a national level, controversy surrounding the RN’s active role in the management of epidural analgesia in laboring patients was growing in the early 2000s.5,6 Some experts asserted that RNs should not perform activities such as initiation and rate adjustments of established continuous epidural analgesia infusions in laboring patients.7,10 Other experts supported the RN’s role in the management of pain relief during labor, including initiating continuous infusions and increasing the rate of epidural analgesia infusions administered to laboring women after insertion and confirmation of correct epidural catheter placement by a qualified anesthesiologist or certified registered nurse anesthetist (CRNA).4,9,11 Obstetric anesthesia experts underscored the belief that women requesting epidural analgesia during labor should not be deprived of the therapy based on lack of anesthesiologist coverage and proposed solutions.9 Boards of nursing in several states had begun to exclude nurses in labor and delivery from perform-
ing these tasks, and many hospitals restricted the role of the RN in the management of epidural analgesia in laboring patients.3 These constraints in RN practice in the management of labor pain occurred at the same time that RNs and nurse midwives in other countries, such as the United Kingdom and Australia, were establishing an abundant experience of safely performing the same tasks with epidural infusions in laboring patients.12–14 The impact of this RN role restriction on the availability of epidural analgesia for women who desire the therapy is unknown, but nonetheless concerning.3 The Labor Epidural Nurse Safety (LENS) study was undertaken to determine if specially trained RNs could initiate and increase the rate of labor epidural analgesia continuous infusions without adversely affecting maternal and fetal/neonatal outcomes. The overarching goals of the LENS study are to expand the RN’s role in the management of labor pain and help bridge the gap between anesthesia providers and their patients who receive epidural analgesia during labor.
Literature Review The literature was searched from 2000 to 2013 in MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Health Source: Academic Edition, PubMed, and Cochrane Database of Systematic Reviews. Although no research that addressed the RN’s role in the labor epidural infusions in the United States was found, a substantial body of literature demonstrating the safety and efficacy of continuous epidural infusions and patient-controlled epidural analgesia (PCEA) during labor was identified and reviewed.15–27 PCEA allows patients to manage their own pain by pressing a button on an infusion device to deliver a dose of analgesic; it has been shown to be a highly effective mode of labor pain management.28 The prevalence of patients safely and effectively managing their own labor pain, according to their individual needs, underscores the appropriateness of specially trained RNs being able to perform similar functions.4,11
Research Methods The LENS study consisted of two parts. The first part was a 10-year retrospective medical records review of the outcomes of 2,568 laboring women for whom epidural catheters had been placed and
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Table 1. Registered Nurse (RN) Training Requirements 1. The RN will a. Attend mandatory educational lectures related to epidural analgesia in the laboring patient i. Achieve a passing score on written examination b. Attend mandatory skill demonstration and return-demonstration sessions i. Demonstrate to an anesthesia provider or a senior RN the proper technique for all skills related to epidural analgesia in the laboring patient 2. After completion of the above requirements, the RN will be able to a. Demonstrate an understanding of hospital policy and procedure regarding the administration and management of epidural analgesia in the laboring patient b. Demonstrate the acquired knowledge of anatomy, physiology, pharmacology, side effects, and complications related to the analgesia technique and medications being administered to the laboring patient c. Assess the laboring patient’s total care needs (physiologic and emotional) while receiving epidural analgesia d. Use monitoring modalities, interpret physiologic responses, and initiate nursing interventions to ensure optimal patient care during epidural analgesia in the laboring patient e. Anticipate and recognize potential complications of epidural analgesia in the laboring patient with regard to the epidural catheter, infusion device, and medications being used f. Recognize emergency situations and institute nursing interventions in compliance with established institution policies, procedures, guidelines, and anesthesia provider’s orders g. Demonstrate the cognitive and psychomotor skills necessary for use and removal of the epidural catheter and infusion device h. Demonstrate knowledge of the legal ramifications of the management and monitoring of epidural analgesia in the laboring patient, including the RN’s responsibility and liability in the event of untoward reactions or lifethreatening complications i. Identify patient/family educational needs and limitations and provide the patient/family with information/education regarding epidural analgesia and the infusion device i. Contact anesthesia provider as needed for provision of medical information 3. The RN will participate in mandatory annual competency review, including demonstrating correct skill technique and achieving a passing score on an annual written examination Data from Pasero C, Eksterowicz N, Primeau M, Cowley C. Registered nurse management and monitoring of analgesia by catheter techniques: Position statement. Pain Manag Nurs. 2007;8:48–54.
verified by an anesthesiologist or CRNA, then continuous epidural infusion initiated, and basal rate or PCEA dose increased, if needed, within specified parameters by specially trained labor and delivery RNs (see Table 1 for RN training requirements). After considering the results of the first part of the study, the primary author received approval to undertake a second part with the goal of comparing the outcomes of the neonates born to the 2,568 women in the first part of the study with neonates born to mothers who received PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists and/or CRNAs at two control sites. The second part of the study evaluated only neonatal outcome data because maternal outcome data were not available for analysis at the two control sites. Internal Review Board (IRB) approval was obtained at the experimental and control sites
before conducting the data collections; none of the IRBs required patient consent. The first part of the LENS study was conducted at the Bay Area Hospital in Coos Bay, Oregon. Maternal outcomes were measured as the incidences of clinically significant hypotension and sentinel events, such as respiratory distress, cardio/respiratory distress, loss of consciousness, and seizures associated with the administration of epidural analgesia during labor. Hypotension was defined as a systolic blood pressure (BP) less than 90 mm Hg requiring the administration of ephedrine per hospital protocol. Hypotensive episodes that occurred within 20 minutes of the RN’s initiation or rate increase of a continuous epidural infusion were considered the result of the RN’s action. A 20-minute interval was selected in accordance to parameters set by
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the anesthesia department, which required close patient monitoring for 20 minutes following initiation of continuous epidural infusion or adjustment of basal rate or PCEA dose. Hypotensive events were identified by reviewing pharmacy accounting records of ephedrine used from 2001 through 2010, and then the medical records of all patients who had received ephedrine for the treatment of hypotension during that time were reviewed. All Unusual Occurrence Reports (the hospital’s method of tracking errors and unexpected outcomes) submitted from 2001 through 2010 for obstetrical analgesia and/or anesthesia were also retrieved and reviewed to identify sentinel events that occurred during the study time frame. Once identified, the medical records of these patients were reviewed, and the details of the events verified. The Bay Area Hospital served as the experimental site for the second part of the study, which evaluated neonatal outcome (Apgar scores). Two other hospitals, AnMed Health in Anderson, South Carolina and St. Joseph’s Medical Center in Tacoma, Washington, were recruited to serve as control sites. The control sites provided PCEA with a continuous infusion initiated and managed exclusively by anesthesiologists or CRNAs. The Apgar scores of the 2,568 newborns born of women who received continuous epidural infusion by specially trained labor and delivery RNs at the experimental site, as described previously, were compared with the Apgar scores of 3,394 newborns at the two control sites combined. The Apgar scores, along with use of oxytocin, misoprostol, or dinoprostone (as possible confounding variables), were collected from the Delivery Log books from all the three sites.
Population and Protocol Of the 6,176 women who delivered at Bay Area Hospital during the 10-year review period, 2,568 delivered vaginally, had epidural analgesia, and received care from specially trained RNs. The only women excluded from participating in the first part of the study were those who had experienced a previously diagnosed intrauterine fetal demise. After placement of the epidural catheter and test dose by an anesthesiologist or CRNA, the specially trained RNs initiated the continuous infusions and increased the basal rate of epidural analgesia infu-
sions, if needed, by 2 mL/hour one time or increased PCEA doses by 2 mL one time. According to standing orders, RNs were required to immediately notify an anesthesiologist or CRNA for any decrease in systolic BP to 90 mm Hg or lower, insufficient pain relief after one increase in basal rate or PCEA dose, respirations , 8 breaths/minute, any other emergency, or any questions or difficulty with pain management. The maternal outcomes of the RN-managed group were evaluated for the first part of the study, and the Apgar scores of the infants of these 2,568 women were collected and compared with those at two control sites to evaluate neonatal outcome for the second part of the study.
Results First Part In the patients who received RN-managed labor epidural analgesia during the 10-year span of the first part of the study, 12 clinically significant hypotensive episodes (decrease in systolic BP to 90 mm Hg or lower) occurred without identifiable associations; one clinically significant hypotensive episode occurred within 20 minutes after a RN intervention, and no sentinel events occurred. Two cases of maternal respiratory distress occurred and were deemed to be unassociated with RN interventions (each of these occurred immediately after an anesthesiologist’s administration of fentanyl and bupivacaine via direct epidural bolus). Second Part The findings in the second part of the study contain an interesting statistical twist, in that most controlled trials attempt to prove that a particular variable causes a change, whereas our hypothesis was that the independent variable would not make a difference. Our interest in the null hypothesis presented the interesting twist because one cannot prove the null.11–14 Independent variable: Specially trained RNs initiating and adjusting continuous epidural analgesia infusions. Null hypothesis: Specially trained RNs initiating and adjusting continuous epidural analgesia infusions will not make a
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difference in maternal/fetal/neonatal outcomes. Conventional hypothesis (which would attempt to disprove the null hypothesis): Specially trained RNs initiating and adjusting continuous epidural analgesia infusions will adversely affect maternal/fetal/neonatal outcomes.
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the past several years. This research also suggests that a specially trained RN staff can help to bridge the gap between anesthesia providers and their laboring patients who receive epidural analgesia, perhaps increasing the availability of epidural analgesia during labor as a pain relief option for more women.
Limitations Descriptive statistics of the Apgar scores at the three sites were similar. The experimental site had lower mean Apgar scores than one of the controls but higher than the other; however, the differences were insignificant. Nonparametric, bootstrapped quantile regression on the median detected no differences between the experimental and the control groups (95% confidence interval, [0,0] for all comparisons). The ordinary least squares regression was statistically significant, but the direction of the effect was inconsistent. Some comparisons showed the experimental site outperforming the control sites and some comparisons showed the reverse. This statistical significance is a result of the very large sample size. The actual effect size is very small, ranging from 0.01 to 0.05 of an Apgar score, and the confidence intervals are within the range of clinical insignificance, which we defined as half of an Apgar score. These results point to evidence in favor of the null hypothesis, that is, the difference in the mean Apgar scores was zero after controlling for the potential confounding variables. There was no evidence that babies born at the hospital where specially trained RNs managed epidural analgesia had a higher risk of a low Apgar score compared with the two hospitals where anesthesia providers managed epidural analgesia.
Discussion and Implications The fact that neither laboring women nor their fetuses/newborns were adversely affected when specially trained RNs initiated and increased the rate of their continuous epidural analgesia infusions during labor has important implications for clinical practice. The data indicate that, with proper initial and ongoing training, RNs in the labor and delivery setting are capable of assuming a role similar to what RNs in other care settings have assumed over
There were limitations to the LENS study that must be considered when interpreting the findings. The scope of this study was restricted by its retrospective nature, making the data subject to more confounding factors. Multicenter prospective studies with larger sample sizes are needed to draw more generalized conclusions. It would have been informative to compare maternal outcomes between the experimental and the two control sites in a similar fashion as the Apgar scores were compared; this is being considered for future reporting. A limitation of the second part of the study was that the Delivery Log content of demographics, history, and medical interventions was not consistent between sites; thus, many of these details could not be included in the second part of the study. Another limitation that could not be controlled was the influence of each institution’s culture surrounding the estimation of Apgar scores. The Apgar score assignment process is described as an objective measure of the newborn’s physical status; however, there is always a degree of subjective interpretation of the score parameters. Apgar scores given to a single infant often vary among the personnel making the assignment. Furthermore, the use of Apgar scores as an outcome criterion provides a vital but limited view of infant well-being.
Conclusion Our findings support the hypothesis that specially trained RNs can safely initiate continuous infusions and increase the basal rate of epidural analgesia infusions or PCEA doses administered to laboring women, after insertion and confirmation of correct catheter placement by a qualified anesthesia provider, without adversely affecting maternal and fetal/neonatal outcomes. More well-
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designed research on the RN’s role in the management of labor epidural analgesia is encouraged. The purpose of the LENS study was to establish the safety of RN initiation and rate increases of continuous epidural analgesia in laboring patients;
future research should evaluate the safety of RN administration of supplemental bolus doses as well in this population. It would also be informative to investigate maternal satisfaction with these nursing practices.
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