Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction

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Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction Mojtaba Fayezizadeh, M.D., Arnab Majumder, M.D., Ruel Neupane, B.S., Heidi L. Elliott, M.D., Yuri W. Novitsky, M.D.* Case Comprehensive Hernia Center, Department of Surgery, University Hospitals Case Medical Center, Cleveland, OH, USA

KEYWORDS: Transversus abdominis plane block; Liposomal bupivacaine; Pain reduction; Narcotic consumption; Hernia repair; Abdominal wall reconstruction

Abstract BACKGROUND: Transversus abdominis plane block (TAPb) is an analgesic adjunct used for abdominal surgical procedures. Liposomal bupivacaine (LB) demonstrates prolonged analgesic effects, up to 72 hours. We evaluated the analgesic efficacy of TAPb using LB for patients undergoing open abdominal wall reconstruction (AWR). METHODS: Fifty patients undergoing AWR with TAPb using LB (TAP-group) were compared with a matched historical cohort undergoing AWR without TAPb (control group). Outcome measures included postoperative utilization of morphine equivalents, numerical rating scale pain scores, time to oral narcotics, and length of stay (LOS). RESULTS: Cohorts were matched demographically. No complications were associated with TAPb or LB. TAP-group evidenced significantly reduced narcotic requirements on operative day (9.5 mg vs 16.5 mg, P 5 .004), postoperative day (POD) 1 (26.7 mg vs 39.5 mg, P 5 .01) and POD2 (29.6 mg vs 40.7 mg, P 5 .047) and pain scores on operative day (5.1 vs 7.0, P ,.001), POD1 (4.2 vs 5.5, P 5 .002), and POD2 (3.9 vs 4.8, P 5 .04). In addition, TAP-group demonstrated significantly shorter time to oral narcotics (2.7 days vs 4.0 days, P ,.001) and median LOS (5.2 days vs 6.8 days, P 5 .004). CONCLUSIONS: TAPb with LB demonstrated significant reductions in narcotic consumption and improved pain control. TAPb allowed for earlier discontinuation of intravenous narcotics and shorter LOS. Intraoperative TAPb with LB appears to be an effective adjunct for perioperative analgesia in patients undergoing open AWR. Ó 2016 Elsevier Inc. All rights reserved.

Y.W.N. is a consultant for C. R. Bard, Inc., and Cooper Surgical, Inc., and has received research support from C. R. Bard, Inc. The remaining authors have no conflict of interest. Presented at 1st World Conference on Abdominal Wall Hernia Surgery, Milan, Italy. April 2015. * Corresponding author. Tel.: 11-216-844-7011; fax: 11-216-8442888. E-mail address: [email protected] Manuscript received October 12, 2015; revised manuscript November 9, 2015 0002-9610/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.12.026

Reduction of postoperative pain remains an essential goal for all surgeons. Pain is not only associated with worsened quality of life measures but can also lead to increased costs associated with hospitalization and prolonged convalescence.1–3 Recently, there has been a shift toward a multimodal approach to postoperative analgesia across many fields of surgery. The goal is not only a reduction of pain but also decreased narcotic usage, with minimization of associated side effects.4–6 One modality used for general

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surgical procedures is the transversus abdominis plane (TAP) block, a regional anesthetic technique that blocks the neural afferents of the anterolateral abdominal wall. The efficacy of this technique is reliant on interrupting the nociceptive signals carried from the afferent neurovascular bundles derived from the ventral rami of T6-L1, which travel between the internal oblique and transversus abdominis muscles.7 As traditionally described, a TAP block (TAPb) is performed with insertion of a needle into the triangle of Petit that is bounded by the latissimus dorsi muscle posteriorly, the external oblique muscle anteriorly, and the iliac crest inferiorly. The needle penetrates the abdominal wall until the TAP is accessed and a longacting local anesthetic is delivered8 (Fig. 1). More recently, ultrasound guidance has been used for further precision and delivery under radiographic visualization.9 For midline abdominal procedures, TAPb has been performed under direct visualization bilaterally by the surgeon with reported clinical efficacy.10 Several studies have demonstrated the benefit of TAPb during abdominal surgery in regard to reduction of postoperative pain, narcotic consumption, and length of hospital stay. Petersen et al11 reviewed 7 randomized clinical trials (n 5 364), investigating the utility during of TAPb during abdominal surgery and found significant reductions in postoperative opioid requirements along with reported pain scores. Furthermore, reductions were also seen in rates of opioid-related side effects including sedation and postoperative nausea and vomiting. Specifically, in three of the trials, McDonnell et al8,12,13 and Carney et al12,13 demonstrated the efficacy of TAPb in reducing postoperative pain in the first 24 to 48 hours in patients undergoing large bowel resection, elective cesarean, and total abdominal hysterectomy.

Similarly, in patients undergoing laparoscopic cholecystectomy, a review by Keir et al14 recently concluded that TAPb in laparoscopic cholecystectomy leads to a reduction in pain scores and analgesic requirement. Finally, by adding TAPb to their postoperative recovery pathway, Delaney and Favuzza15 reported a reduction in length of stay (LOS) in patients undergoing elective laparoscopic colectomy without an increase in complication or readmission rates. Pain after major open ventral hernia repair (VHR)/ abdominal wall reconstruction (AWR) is one of main issues encountered by surgeons postoperatively. Large incisions coupled with extensive tissue dissection combined with mesh placement and fixation have all contributed to the fact that hernia repairs are among the most painful surgical procedures performed. Although the use of TAPb in other abdominal procedures has been studied, its utilization in patients undergoing major open VHR/AWR has not been investigated to date. We used the TAPb technique by directly accessing the TAP plane through the cut edge of the transversus abdominis muscle (Fig. 2) and using a long-acting multivesicular liposomal formulation of bupivacaine; EXPAREL (Pacira Pharmaceuticals, Parsippany, NJ). In this study, we aimed to evaluate the effects of TAP block with EXPAREL (TAPb-E) on postoperative outcomes for patients undergoing major AWR. We hypothesized that the use of TAPb-E results in significant improvement in postoperative pain, reduction in opiate requirement, and shorter hospitalizations.

Figure 1 Traditional TAP block deliverydtransverse section through the abdominal wall at the level of the lumbar triangle of Petit (TOP). The floor of the triangle is composed, from superficial to deep, of the fascial extensions of external oblique, internal oblique, and transversus abdominis, respectively, and the peritoneum. The needle is shown in the transversus abdominis plane, and the fascial layers have separated as a result of the injection of local anesthetic. EO 5 external oblique; IL 5 longissimus iliocostalis; IO 5 internal oblique; LD 5 latissimus dorsi; LS 5 lumbar spine; MM 5 multifidus muscle; PM 5 psoas major; QL 5 quadratus lumborum; ST 5 subcutaneous tissue; TA 5 transversus abdominis.

Methods After obtaining appropriate institutional review board approval, we identified 50 consecutive patients undergoing open AWR who received TAPb-E. The data were collected prospectively as a part of a Continuous Quality Improvement project and then reviewed. Inclusion criteria included open VHR performed with posterior component separation via transversus abdominis muscle release16 and sublay synthetic mesh placement without any concomitant procedures. We excluded patients with history of chronic pain or narcotic use. In addition, we excluded patients undergoing repairs with concomitant intestinal resection, along with those who

Figure 2 Intraoperative TAP block deliveryd20 cc of liposomal bupivacaine (EXPAREL) is delivered using the cut edge of transversus abdominis to access the TAP under direct visualization.

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TAP block during abdominal wall reconstruction

remained intubated or required transfer to a higher level of care, as these could be confounders for measuring postoperative pain and narcotic consumption. The study group was compared with a matched historical control of 50 patients undergoing AWR without TAPb-E. In both groups, oral narcotics were instituted when patients tolerated clears, had their pain controlled without patient-controlled analgesia (PCA); all discharge criteria were similar between the groups. Pertinent demographic data were assessed, including age, sex, body mass index, and comorbidities. We also collected patient characteristics including history of hernia and prior repairs, history of wound infection, and wound classification based on Centers for Disease Control and Prevention.17 Perioperative data including American Society of Anesthesiologists physical status score, hernia defect size, mesh size, number of fixating sutures, operative (OR) time, and estimated blood loss were also gathered. The primary outcomes for this study were postoperative pain data including daily narcotic usage in morphine equivalents, daily numeric rate scale (NRS) pain score, time to oral narcotics (TON), and LOS. LOS was defined as the total numbers of days of hospitalization after surgery. As part of our standard postoperative care, patients receive multimodal analgesia. All patients receive a PCA pump using intravenous (IV) hydromorphone in .1- , .2- , or .4-mg doses every 6 minutes or IV morphine in 1-mg, 2mg, or 4-mg doses every 6 to 10 minutes. All patients are given IV or oral/per os acetaminophen 1 g scheduled every 6 hours along with Gabapentin 100- to 300-mg TID. Once patients tolerate oral fluids and their pain is adequately controlled, their PCA pump is discontinued and they are transitioned to oral oxycodone 5 to 10 mg as needed every 4 to 6 hours. In addition, oral or IV nonsteroidal antiinflammatory drug (Ketorolac 15 mg IV every 6 hours) is used for breakthrough pain which is transitioned to oral nonsteroidal anti-inflammatory drug once tolerating per os. The total amount of narcotic used by each patient on the OR day, postoperative day (POD) 1, 2, and 3 was calculated and converted to morphine equivalents as follows: Dilaudid 1 mg 5 Morphine 4 mg; Oxycodone 10 mg 5 Morphine 15 mg; Fentanyl patch 10 mcg/hr 5 Morphine 24 mg. The NRS is an 11-point pain scale with scores between 0 and 10, which were documented by nurses 4 to 5 times daily before narcotic administration. The average NRS score of each day was calculated for the OR day and PODs 1, 2, and 3. Data analysis was performed with IBM SPSS, ver. 18.0 (IBM Co., Armonk, NY). The outcomes in the 2 groups were compared with Student t test for continuous variables or Fisher’s exact test for categorical variables, when appropriate. A P value less than .05 was considered significant.

Surgical procedure and TAP block All patients underwent open retrorectus VHR with posterior component separation using transversus abdominis

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release (TAR), as previously described.16 In summary, TAR involves incision of the ventral surface of the posterior rectus sheath just medial to the linea semilunaris once retrorectus dissection is completed. The transversus muscle fibers and aponeurosis are identified, isolated, and divided, taking care not to create fenestrations in the underlying peritoneum and transversalis fascia. Once complete, the muscle is reflected away from the posterior sheath developing a large retromuscular pocket suitable for mesh placement. Synthetic mesh is then placed in sublay fashion. To perform the TAPb, we used the cut lateral edge of the transversus muscle to access the TAP under direct vision (Fig. 2). In our method, 20 ml of EXPAREL is volume expanded with 150 ml of normal saline to a total volume of 170 ml. We then add 50 ml of .25% bupivacaine to the mixture for a total volume 220 ml. At this point, 20 ml of the solution is drawn up and injected into the TAP under direct visualization at 5 vertical levels (subcostal, upperabdominal, mid-abdominal (!2), and pelvic side wall) on each side of the abdominal wall. The remaining 20 ml are typically used as local anesthetic for fixation points and/or midline closure.

Results Demographics Fifty consecutive patients undergoing open AWR using TAR with TAPb-E (TAP-group) were compared with a matched historical cohort of 50 patients who underwent TAR reconstruction without TAPb-E (control group). Table 1 summarizes the demographics of the two groups. There were no significant differences between the two groups in any patient or hernia characteristics. Mean age for TAP-group was 60 vs 59 in the control group (P 5 .66). There was a slightly higher, but nonsignificant proportion of females in the control group (72% vs 56%, P 5 .14). Average body mass index was similar, approximately 36 in both the groups. ASA class was 3 in both cohorts. Incidence of comorbidities was similar across the groups. Both cohorts had a similar frequency of recurrent hernias (TAP 62% vs control 64%, P 5 1.00). In addition, OR details were similar, with nonsignificant differences in defect size, wound class distribution, and average number of transabdominal sutures used. Only OR time was noted to be significantly longer in the TAP-group (307 6 113 min vs 262 6 82 min, P 5 .03).

Outcomes Table 2 summarizes the pain and temporal outcomes in the 2 groups. In the postoperative period, the use of opiates was significantly less in the TAP-group until POD 3. The reduction was significant on OR day (9.5 6 1.0 vs 16.5 6 2.2, P 5 .005), POD 1, (26.7 6 2.9 vs 39.5 6 4.1, P 5 .01), and POD 2 (29.6 6 3.2 vs 40.7 6 5.3,

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4 Table 1

Patient characteristics

Characteristic Demographics Age (y) Gender (Female) BMI (kg/m2) ASA class Comorbidities DM COPD Recurrent hernia Operative details Operative time (min) Defect size (cm2) Wound class (I/II) Average transabdominal suture number (range)

TAP-group (n 5 50)

Control group (n 5 50)

Mean 6 SEM, n (%)

Mean 6 SEM, n (%)

60 6 12 28 (56%) 35.5 6 7.8 3

59 6 14 36 (72%) 36.1 6 7.7 3

15 (30%) 7 (14%) 31 (62%)

11 (22%) 10 (20%) 32 (64%)

307 6 113 361 6 210 30/20 (60%/40%) 2.6 (0–8)

262 6 82 312 6 222 39/11 (78%/22%) 2.9 (0–8)

P value .66 .14 .66 .44 .49 .79 1.00 .03 .27 .08 .95

Bold values indicate statistical significance. ASA 5 American Society of Anesthesiologists; BMI 5 body mass index; COPD 5 chronic obstructive pulmonary disease; DM 5 diabetes mellitus; SEM 5 standard error of mean; TAP 5 transversus abdominis plane.

Table 2

Pain outcomes

Outcome Narcotic use (mg Morphine) OR day POD1 POD2 POD3 NRS pain score (0–10) OR day POD1 POD2 POD3 Time to oral narcotics (d) Length of stay (d)

TAP-group (n 5 50)

Control group (n 5 50)

Mean 6 SEM

Mean 6 SEM

9.5 26.7 29.6 28.9

6 6 6 6

1.0 2.9 3.2 3.7

16.5 39.5 40.7 39.0

6 6 6 6

2.2 4.1 5.3 6.6

5.0 4.2 3.9 4.3 2.7

6 6 6 6 6

.3 .3 .2 .2 .2

7.0 5.5 4.8 4.6 4.0

6 6 6 6 6

.3 .3 .3 .2 .2

5.2 6 .4

6.8 6 .4

P value

.005 .01 .047 .19

,.001 .002 .048 .7 ,.001 .006

Bold values indicate statistical significance. NRS 5 numerical rating scale; OR 5 operative; POD 5 postoperative day; SEM 5 standard error of mean; TAP 5 transversus abdominis plane.

with TAP block delivery in any patients nor were there any allergic reactions to EXPAREL.

Comments Alleviation of postoperative pain remains at the forefront of recent perioperative care measures, with benefits extending beyond patient welfare and financial metrics. Numerous studies have shown the benefits of multimodal pain control regimens in contrast to those centered solely around narcotics.18–21 The addition of TAP block has recently emerged as an important part of multimodal pain control strategies in multiple surgical disciplines. With efficacy reported in various open and laparoscopic procedures,8,13,15,22,23 we sought to expand the use of TAPb for patients undergoing abdominal wall reconstruction, where the effects of blocking afferent nociceptive signals to improve perioperative pain would be of utmost importance. PostoperaƟve NarcoƟc Usage Morphine Equivalents (mg)

P 5 .047; Fig. 3). Mirroring the trend seen with narcotic consumption, the NRS pain scores of the TAP-group to the control group revealed that average pain scores were significantly less on OR day (5.0 6 .3 vs 7.0 6 .3, P ,.001), POD 1 (4.2 6 .3 vs 5.5 6 .3, P 5 .002), and POD 2 (3.9 6 .2 vs 4.8 6 .3, P 5 .048) only (Fig. 4). Time to oral narcotics was also significantly less in the TAP-group (2.7 6 .2 days vs 4.0 6 .2 days, P ,.001; Fig. 5). Finally, the median LOS was significantly shorter in the TAP-group (5.2 6 .4 days vs 6.8 6 .4 days, P 5 .006; Fig. 6). There were no complications associated

50 45 40 35 30 25 20 15 10 5 0

40.7

39.5 26.7 9.5

29.6

39.0 * 28.9*

16.4

OR Day

POD 1 TAP Block

POD 2

POD 3

Control

Figure 3 Postoperative narcotic consumption in morphine equivalents for the TAP-group vs control group. Data are expressed as mean with 95% confidence interval. * Not statically significant.

M. Fayezizadeh et al.

TAP block during abdominal wall reconstruction Length of Stay 8 7 6 5

Days

NRS Pain Score

PostoperaƟve Pain Scores 10 9 8 7 6 5 4 3 2 1 0

7.0 5.0

4.2

5.5 3.9

4.8

4.3*

4.6*

POD 1 TAP Block

POD 2

POD 3

Control

Figure 4 NRS pain scores for TAP-group vs control group. Data are expressed as mean with 95% confidence interval. NRS 5 numeric rating scale. * Not statically significant.

In our practice, the vast majority of patients undergo AWR using posterior component separation with TAR. This affords us a large sublay space for prosthetic reinforcement of the visceral sac. Unfortunately, significant postoperative pain after AWR is common owing to the large incisions involved, along with the extensive manipulation of the abdominal wall during component separation and potential transfascial mesh fixation. Although parenteral and enteral methods of analgesia are widely used postoperatively, it is ultimately a treatment of the symptom rather than the cause. TAPb may allow us to interrupt the transmission of pain signals via local anesthetic delivered directly to the afferent nerves. Our surgical approach is unique in that it offers an opportunity for a very precise and reproducible TAPb given that we can directly visualize the entire reflected transversus muscle (Fig. 2). The TAP plane lies just ventral to the reflected muscle and can be easily accessed under direct visualization with delivery of local anesthetic to the neurovascular bundles within. Our modification to TAPb with the addition of long acting liposomal bupivacaine has been shown in colorectal literature to maximize the duration of anesthetic effect for as long as 72 hours.24 Furthermore, the liposomal formulation of bupivacaine has seen use as a local anesthetic in the orthopedic realm with results equivalent to traditional nerve

Time to Oral NarcoƟcs 4.5 4 3.5 3

Days

4 3

6.8 5.2

2 OR Day

2.5 2 1.5

5

4.0 2.7

1 0.5 0 TAP Block

Control

Figure 5 Time to oral narcotics for TAP-group vs control group. Data are expressed as mean with 95% confidence interval.

1 0 TAP Block

Control

Figure 6 Length of stay for TAP-group vs control group. Data are expressed as mean with 95% confidence interval.

blockade, as well as in breast surgery with effectiveness superior to traditional oral and parenteral analgesic methods.25,26 We hypothesized that extension of the nerve blockade provided by TAPb-E, well past the usual 4 to 6hour duration of traditional bupivacaine, would result in measurable efficacy in terms of decreased postoperative pain and narcotic use for this challenging cohort of patients. Our study demonstrated significant improvement in postoperative analgesia in terms of both reported pain scores and narcotic consumption. Decrease in average pain score was largest in the immediate postoperative period with an average reduction of 29% (2 points) on the OR day and a 19% reduction in pain scores by POD 2. Not surprisingly, by POD 3, there was no significant difference in reported pain scores. We believe this correlates with pharmacokinetics of EXPAREL. Given the expected 72hour duration of the drug, the beneficial effects of the TAPb-E by POD 3 were not seen. Narcotic consumption also mirrored this trend with significant reduction in morphine equivalents consumed in the immediate postoperative period into POD 2. Again the reduction was largest on the OR day, with a 42% reduction in narcotic use compared with the control group, with a decline to only a 27% by POD 2. Similarly, on POD 3, there was nonsignificant reduction in the average narcotic consumption between the groups. The expected correlation between reductions in NRS pain scores and reduced narcotic consumption is evidence that aside from a subjective decrease in pain, patients actually require less narcotic because of TAPb-E. Although it is evident from our results that the effective duration of the TAPb was approximately 48 to 72 hours, the anesthetic effect may not have been of constant potency. The difference between the 2 groups in terms of pain score and narcotic consumption was largest in the immediate postoperative period with a steady decline in as the blockade faded. The immediate maximization in efficacy may be also due to the standard bupivacaine that is combined with the liposomal form which provides a potent but short lasting blockade. Once the standard formulation has worn off, the liposomal formulation is left which

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continues to provide blockade with a slower rate of decay. Ultimately, the immediate reduction of pain from surgery resulted in overall lower total narcotic exposure thus reducing the potential side effects of opioid use as well. Although the advantage of lower pain scores and narcotic consumption was no longer present by POD 3, we did demonstrate a 33% reduction in time to oral narcotics and/ or withdrawal of IV PCA pump. This expedited change in analgesic method helped to prepare patients for discharge on a completely oral analgesic regimen which can often be a limiting factor for patients who are hesitant to convert to oral analgesics due to fear of inadequate pain control. Specifically, in regard to an expedited conversion, aside from the improvement in patient welfare due to less overall pain, we also observed a 24% reduction in median LOS in the TAP cohort. Although the length of hospitalization is multifactorial, we found improved pain control and decreased opioid intake in the early postoperative period may have been one of the main reasons for shorter hospital stays. Although we were not able to obtain precise hospital cost/charges for our cohorts, decreased duration of PCA use and a nearly 2-day reduction in hospitalization should offset the cost of EXPAREL and result in significant overall financial benefits. Interestingly, we observed that the OR time in the TAPgroup was on average 45 minutes longer than the controls; however, we do not believe this was as a result of the additional time needed to perform the TAP block. In our experience, bilateral blocks can be administered in less than 5 minutes per side. Importantly, we detected no intraoperative complications related to TAPb administration, and we observed no adverse reactions to the long-acting bupivacaine. We believe that after a short learning curve, TAPb can be applied safely to a broad range of hernia patients. Our findings favor the use of TAPb with liposomal bupivacaine during VHR. However, our study has limitations associated with a retrospective nature of this study. Although the groups were matched according to patient and hernia characteristics, selection bias may have occurred. In addition, despite a moderate sample size, variations in patients’ pain tolerance and liberal use of patient-controlled analgesics is a subjective issue dependent on different individual aspects. Although these findings appear promising, we believe future prospective randomized placebo controlled trial is warranted.

control. Although the length of hospitalization is multifactorial, TAP block with liposomal bupivacaine allowed for shorter length of stay with implications for reduced cost of hospitalization. Overall, we advocate intraoperative TAP block with liposomal bupivacaine, as part of a multimodal approach that improves perioperative analgesia and outcomes in patients undergoing open abdominal wall reconstruction.

Conclusions Postoperative analgesia remains of paramount concern across many fields of surgery, however, particularly so for maximally invasive cases such as open abdominal wall reconstruction. We discovered that intraoperative TAP block with long-acting liposomal bupivacaine was associated with significant reductions in narcotic consumption, earlier discontinuation of IV narcotics, and improved pain

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