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Treatment of postpartum pain
Treatment of postpartum pain VINCENT NOLA, M.D. -H . L . BERTE L S E N, M . D . JAMES WEATHERHOLT, M.D. San jose, California
T H E problem of pain continually confronts all physicians. In the practice of obstetrics pain is of major concern, especially during labor and delivery. Mter delivery a large proportion of patients have little or no pain and the obstetrician often tends to minimize the analgesic needs of the majority of puerperal women. It is just as important to keep the patient comfortable during this period as it was during her labor and delivery. One of the most common complaints during the immediate puerperium is "after pains," especially in the multiparous patient. Greenhill 1 states that 75 per cent of multiparous patients will complain of "after pains." Blakely2 feels that these pains are due to ischemia of the uterus as the result of uterine contractions. The primipara rarely complains of "after pains" and, if she does, one must consider causes such as retention of large blood clots, infection, or retention of placental tissue. The second most common site of pain is the perineum as the result of edema in the episiotomy or laceration sites. One must always rule out a hematoma as the cause of pain in this area. As the edema subsides, the pain lessens. Hemorrhoids and anal fissures will result in troublesome pain, and proper treatment should be instituted early in order to hasten recovery. Other causes of pain during the puerperium are bladder pain secondary to infection or overdistention of the bladder, super-
ficial or deep vein thrombophlebitis, endometritis, parametritis, and infected episiotomies and lacerations. Breast pain is also troublesome hut usually does not occur until the third or fourth day, when the breasts become engorged. However, painful nipples often become disconcerting, especially to a nursing mother. In most obstetric services, routine postpartum orders include an analgesic. The usual order is for codeine with aspirin. This narcotic necessitates considerable paper work and control by the nursing staff and is considered fraught with undesirable side effect liability. The recent advent of oral, nonnarcotic analgesics would seem, then, especially useful in this situation. However, these have been only sporadically evaluated in postpartum patients and with contradictory results in some cases. 3 • 4 Ethoheptazine citrate, an agent which seemed to hold great promise in that it has been demonstrated to be an effective analgesic 5 alone and, combined with aspirin (Zactirin), to be equivalent to codeine and, in graded doses, to produce a dose-response curve, 6 has been studied in postpartum pain. 7 However, this study was uncontrolled and did little to clear the confusion. Parese8 has commented on the value of using tranquilizing agents in conjunction with analgesics. Splitter9 and Harsha10 have reported excellent results using this rationale and a combination of meprobamate, ethoheptazine citrate, and acetylsalicylic acid (Equagesic). Therefore, it was decided to investigate
From Santa Clara County Hospital.
261
262
July \.). lt. & (;ynec
Nolo, Bertelsen, and Weatherholt
Table I. Comparison of groups for similarity
Per cent multiparas Age of multiparas Per cent primiparas Age of primiparas No. premature infants No. stillborn infants Per cent complications Per cent episiotomies Midline Mediolateral Per cent lacerations First degree Second degree Third
Test
i Standard
drug
I I
drug 80 26 20
81
25
19
:w
18
6 I
11 3 9
71
13 62
27
24
44 11
13
4 4 3
38 10 :; 0
Table II. Types of anesthesiaper cent of total deliveries
Testdrug Standard drug
Subarachnoid block
Caudal
5
None
Local
Pudendal block
7
17-20
56
12
15
16-20
51
12
Table III. Distribution of pain occurrence
I
I
jNone Once Twice
Test drug Standard Total
I> Twice ITotal
30
22
15
33
100
23
14
25
31
93
53
36
40
64
193
the efficacy of this combination measured against our standard of codeine and aspirin for routine use in postpartum patients. At the same time, it was hoped to estimate the occurrence and severity of postpartum pain and the side effect liability of the agents.
patients that wen· excluded from this sene~ wen· those who were delivered by C<"sarean section. The analgesic problem in these patients was felt to bt> of a different kind. All patients, during the first 24 hours following delivery, were given identical capsules. each of which contained either ( 1) 16 mg. of codeine with 325 mg. of aspirin or '· 21 150 mg. of meprobamate, 75 mg. of ethoheptazine citrate, and 250 mg. of aspirin. The dosage ·was 2 capsules every -t hours for 6 doses. They also received 1 tablet of methylergonovine maleate, 0.2 mg .. e\·ery 4 hours for 6 doses. The unknowns were packaged in bottles of 50 capsules which were lettered A, B, C, or D. This way the code was changed ( 2 drugs, 4 code letters) halfway through the study to prevent "identification" of certain properties with a specific code letter. The first 50 patients received series A, the second 50 r<"ceh-ed series B, the third 50 received series C, and the remaining 43 received series D. Since studies in the four groups were each accomplished rapidly, we felt time would not be a variable of any magnitude and the control of recording error afforded would be very worthwhile. There were actually four "unknowns" in this way and the participating doctor and nursing staff were blind. The code was not broken until the results were tabulated by groups. The groups were then combined for final analysis. The routine administration of medications afforded the means to question each patient every 4 hours on degree of pain present, degree of relief afforded from the previous dose of drug. and side effects experienced. These data were recorded at the bedside immediately after medication was given. There was no specific questioning as to side effects, only a general inquiry as to wellbeing, in order to a\·oid suggestion.''
Method and material
In the maternity division of Santa Clara County Hospital, a double-blind study was carried out on 193 postpartum patients. These patients were selected in succession as they were delivered vaginally. The only
Results
The total study included 193 patients, 100 on the "test" medication and 93 on the standard. Table I demonstrates the equivalence of the patient groups according to
Volume 84 Number Z
Treotment of postpartum pain
263
Table IV. Analgesic effectiveness Degree of relief
ITest !
13
13
18
28
115 160
103 153
2
3
drug I Standard 1 2
14
+ Total
A-
= 0.63
218
-
26
26 98
72 95
338
338
46,920
42,024
D
E
2,338
408
2
2,744
167
313
X
1,764
1,503
-··---
313
c
B C + !>
t•=c+l xsR'--2t2
26 +6 23
9
A 12
7 5
D +A
Rl=2A
p <0.5, >0.3
various criteria which could affect their response to pain. Table II demonstrates that the labor analgesics and anesthetics were equally distributed in the groups, a factor which could influence the occurrence of pain. Table III demonstrates a startling finding of this study. Fully 27 per cent of patients never experienced pain and 46 per cent experienced no pain or some pain only very briefly. When this 46 per cent is added to Beecher's 11 figure of 32.5 per cent for placebo effect, the remarkable 75 per cent placebo effect reported by Orkin, Joseph, a,nd Helrich12 can be accounted for. The factor of patient need for analgesia is obviously a very large one, much more so than we had anticipated. Table IV compiles and analyzes the data on analgesic effectiveness. The study was designed to use the rank-t test as described by Bross/ 3 and the data are so analyzed. In the analysis of degree of relief, 1 indicates no relief and 4 indicates complete relief. Columns 1 and 2 indicate that the test drug was more effective, but analysis shows that the difference would be due to chance about 40 per cent of the time. This is then really a similarity in effect. Table V reviews the side effects reported by the patients. While codeine and aspirin did produce more unpleasant effects in more people, it is notable that constipation was not reported in either group and that the side effect liability in the total group is very low and inconsequential.
Comment
A study has been conducted to determine ( 1 ) the necessity for postpartum analgesic medication and (2) the possibility of eliminating routine postpartum narcotic drugs to reduce the administrative load on the nursing staff and the side effect onus put on the physician. A double-blind evaluation of our standard drug, codeine and aspirin, and a combination drug, ethoheptazine with aspirin and meprobamate, in unselected postpartum patients in comparable groups showed equal and very satisfactory effectiveness for the two. Additionally, the nursing staff commented on the increased relaxation afforded by the coded capsules A and C, the nonnarcotic combination. A remarkable incidence of 46 per cent of the patients studied either experienced no postpartum pain ( 27 per cent) or very little for a brief period ( 19 per cent) .
Table V Test drug Side effects
Times I Patients Times reported reporting reported
2 0
0
0
Vomiting
0
3
3
Drowsiness
5
4
11
0
0
3
6* 1*
7
5
17
Nausea
Total
10
*One patient reported three incidences each of drow· siness and shakiness.
264
Nola, Bertelsen, and Weatherholt
Summary 1. A double-blind comparison of analgesic
effectiveness of codeine and aspirin with a nonnarcotic combination (Equagesic) was made in postpartum patients. 2. Analgesic effectiveness was very good for both drugs and statistically identical.
REFERENCES
1. Greenhill, J. P.: Obstetrics, ed. 11, Philadelphia, 1955, W. B. Saunders Company. 2. Blakely, S. B.: New York J. Med. 39: 411, 1939. 3. Santiago, F. S., and Danforth, D. N.: Obst. & Gynec. 13: 22, 1959. +. Prockop, L. D., Eckenhoff, J. E., and McElroy, R. C.: Obst. & Gynec. 16: 113, 1960. 5. Cass, L. J., Frederik, W. S., and Bartholomay, A. F.: J. A. M. A. 166: 1829, 1958. 6. Cass, L. J., and Frederik, W. S.: Canad. M. A. J. 83: 831, 1960.
Am.
July 15, 1962 & Gyncc.
J. Obst.
3. The time saved by elimination of a narcotic in postpartum patient care, the decreased incidence of side effects, and the additional relaxation afforded make the nonnarcotic combination the medication of choice.
7. McCarty, W. D., and Ullery, J. C.: Postgrad. Med. 26: 865, 1959. 8. Parese, D. M.: J. A. M. A. 175: 75, 1961. 9. Splitter, S. R.: Current Therap. Res. 2: 189, 1960. 10. Harsha, W. N.: J. Oklahoma M. A. 54: 12, 1961. 11. Beecher, H. K.: J. A. M. A. 159: 1602, 1955. 12. Orkin, L. R., Joseph, S. I., and Helrich, M.: New York J. Med. 57: 71, 1957. 13. Bross, I. D. J.: Fed. Proc. 13: 815, 1954. 2016 Forest Ave. San Jou. California
T H E problem of pain continually confronts all physicians. In the practice of obstetrics pain is of major concern, especially during labor and delivery. Mter delivery a large proportion of patients have little or no pain and the obstetrician often tends to minimize the analgesic needs of the majority of puerperal women. It is just as important to keep the patient comfortable during this period as it was during her labor and delivery. One of the most common complaints during the immediate puerperium is "after pains," especially in the multiparous patient. Greenhill 1 states that 75 per cent of multiparous patients will complain of "after pains." Blakely2 feels that these pains are due to ischemia of the uterus as the result of uterine contractions. The primipara rarely complains of "after pains" and, if she does, one must consider causes such as retention of large blood clots, infection, or retention of placental tissue. The second most common site of pain is the perineum as the result of edema in the episiotomy or laceration sites. One must always rule out a hematoma as the cause of pain in this area. As the edema subsides, the pain lessens. Hemorrhoids and anal fissures will result in troublesome pain, and proper treatment should be instituted early in order to hasten recovery. Other causes of pain during the puerperium are bladder pain secondary to infection or overdistention of the bladder, super-
ficial or deep vein thrombophlebitis, endometritis, parametritis, and infected episiotomies and lacerations. Breast pain is also troublesome hut usually does not occur until the third or fourth day, when the breasts become engorged. However, painful nipples often become disconcerting, especially to a nursing mother. In most obstetric services, routine postpartum orders include an analgesic. The usual order is for codeine with aspirin. This narcotic necessitates considerable paper work and control by the nursing staff and is considered fraught with undesirable side effect liability. The recent advent of oral, nonnarcotic analgesics would seem, then, especially useful in this situation. However, these have been only sporadically evaluated in postpartum patients and with contradictory results in some cases. 3 • 4 Ethoheptazine citrate, an agent which seemed to hold great promise in that it has been demonstrated to be an effective analgesic 5 alone and, combined with aspirin (Zactirin), to be equivalent to codeine and, in graded doses, to produce a dose-response curve, 6 has been studied in postpartum pain. 7 However, this study was uncontrolled and did little to clear the confusion. Parese8 has commented on the value of using tranquilizing agents in conjunction with analgesics. Splitter9 and Harsha10 have reported excellent results using this rationale and a combination of meprobamate, ethoheptazine citrate, and acetylsalicylic acid (Equagesic). Therefore, it was decided to investigate
From Santa Clara County Hospital.
261
262
July \.). l
Nolo, Bertelsen, and Weatherholt
Table I. Comparison of groups for similarity
Per cent multiparas Age of multiparas Per cent primiparas Age of primiparas No. premature infants No. stillborn infants Per cent complications Per cent episiotomies Midline Mediolateral Per cent lacerations First degree Second degree Third
Test
i Standard
drug
I I
drug 80 26 20
81
25
19
:w
18
6 I
11 3 9
71
13 62
27
24
44 11
13
4 4 3
38 10 :; 0
Table II. Types of anesthesiaper cent of total deliveries
Testdrug Standard drug
Subarachnoid block
Caudal
5
None
Local
Pudendal block
7
17-20
56
12
15
16-20
51
12
Table III. Distribution of pain occurrence
I
I
jNone Once Twice
Test drug Standard Total
I> Twice ITotal
30
22
15
33
100
23
14
25
31
93
53
36
40
64
193
the efficacy of this combination measured against our standard of codeine and aspirin for routine use in postpartum patients. At the same time, it was hoped to estimate the occurrence and severity of postpartum pain and the side effect liability of the agents.
patients that wen· excluded from this sene~ wen· those who were delivered by C<"sarean section. The analgesic problem in these patients was felt to bt> of a different kind. All patients, during the first 24 hours following delivery, were given identical capsules. each of which contained either ( 1) 16 mg. of codeine with 325 mg. of aspirin or '· 21 150 mg. of meprobamate, 75 mg. of ethoheptazine citrate, and 250 mg. of aspirin. The dosage ·was 2 capsules every -t hours for 6 doses. They also received 1 tablet of methylergonovine maleate, 0.2 mg .. e\·ery 4 hours for 6 doses. The unknowns were packaged in bottles of 50 capsules which were lettered A, B, C, or D. This way the code was changed ( 2 drugs, 4 code letters) halfway through the study to prevent "identification" of certain properties with a specific code letter. The first 50 patients received series A, the second 50 r<"ceh-ed series B, the third 50 received series C, and the remaining 43 received series D. Since studies in the four groups were each accomplished rapidly, we felt time would not be a variable of any magnitude and the control of recording error afforded would be very worthwhile. There were actually four "unknowns" in this way and the participating doctor and nursing staff were blind. The code was not broken until the results were tabulated by groups. The groups were then combined for final analysis. The routine administration of medications afforded the means to question each patient every 4 hours on degree of pain present, degree of relief afforded from the previous dose of drug. and side effects experienced. These data were recorded at the bedside immediately after medication was given. There was no specific questioning as to side effects, only a general inquiry as to wellbeing, in order to a\·oid suggestion.''
Method and material
In the maternity division of Santa Clara County Hospital, a double-blind study was carried out on 193 postpartum patients. These patients were selected in succession as they were delivered vaginally. The only
Results
The total study included 193 patients, 100 on the "test" medication and 93 on the standard. Table I demonstrates the equivalence of the patient groups according to
Volume 84 Number Z
Treotment of postpartum pain
263
Table IV. Analgesic effectiveness Degree of relief
ITest !
13
13
18
28
115 160
103 153
2
3
drug I Standard 1 2
14
+ Total
A-
= 0.63
218
-
26
26 98
72 95
338
338
46,920
42,024
D
E
2,338
408
2
2,744
167
313
X
1,764
1,503
-··---
313
c
B C + !>
t•=c+l xsR'--2t2
26 +6 23
9
A 12
7 5
D +A
Rl=2A
p <0.5, >0.3
various criteria which could affect their response to pain. Table II demonstrates that the labor analgesics and anesthetics were equally distributed in the groups, a factor which could influence the occurrence of pain. Table III demonstrates a startling finding of this study. Fully 27 per cent of patients never experienced pain and 46 per cent experienced no pain or some pain only very briefly. When this 46 per cent is added to Beecher's 11 figure of 32.5 per cent for placebo effect, the remarkable 75 per cent placebo effect reported by Orkin, Joseph, a,nd Helrich12 can be accounted for. The factor of patient need for analgesia is obviously a very large one, much more so than we had anticipated. Table IV compiles and analyzes the data on analgesic effectiveness. The study was designed to use the rank-t test as described by Bross/ 3 and the data are so analyzed. In the analysis of degree of relief, 1 indicates no relief and 4 indicates complete relief. Columns 1 and 2 indicate that the test drug was more effective, but analysis shows that the difference would be due to chance about 40 per cent of the time. This is then really a similarity in effect. Table V reviews the side effects reported by the patients. While codeine and aspirin did produce more unpleasant effects in more people, it is notable that constipation was not reported in either group and that the side effect liability in the total group is very low and inconsequential.
Comment
A study has been conducted to determine ( 1 ) the necessity for postpartum analgesic medication and (2) the possibility of eliminating routine postpartum narcotic drugs to reduce the administrative load on the nursing staff and the side effect onus put on the physician. A double-blind evaluation of our standard drug, codeine and aspirin, and a combination drug, ethoheptazine with aspirin and meprobamate, in unselected postpartum patients in comparable groups showed equal and very satisfactory effectiveness for the two. Additionally, the nursing staff commented on the increased relaxation afforded by the coded capsules A and C, the nonnarcotic combination. A remarkable incidence of 46 per cent of the patients studied either experienced no postpartum pain ( 27 per cent) or very little for a brief period ( 19 per cent) .
Table V Test drug Side effects
Times I Patients Times reported reporting reported
2 0
0
0
Vomiting
0
3
3
Drowsiness
5
4
11
0
0
3
6* 1*
7
5
17
Nausea
Total
10
*One patient reported three incidences each of drow· siness and shakiness.
264
Nola, Bertelsen, and Weatherholt
Summary 1. A double-blind comparison of analgesic
effectiveness of codeine and aspirin with a nonnarcotic combination (Equagesic) was made in postpartum patients. 2. Analgesic effectiveness was very good for both drugs and statistically identical.
REFERENCES
1. Greenhill, J. P.: Obstetrics, ed. 11, Philadelphia, 1955, W. B. Saunders Company. 2. Blakely, S. B.: New York J. Med. 39: 411, 1939. 3. Santiago, F. S., and Danforth, D. N.: Obst. & Gynec. 13: 22, 1959. +. Prockop, L. D., Eckenhoff, J. E., and McElroy, R. C.: Obst. & Gynec. 16: 113, 1960. 5. Cass, L. J., Frederik, W. S., and Bartholomay, A. F.: J. A. M. A. 166: 1829, 1958. 6. Cass, L. J., and Frederik, W. S.: Canad. M. A. J. 83: 831, 1960.
Am.
July 15, 1962 & Gyncc.
J. Obst.
3. The time saved by elimination of a narcotic in postpartum patient care, the decreased incidence of side effects, and the additional relaxation afforded make the nonnarcotic combination the medication of choice.
7. McCarty, W. D., and Ullery, J. C.: Postgrad. Med. 26: 865, 1959. 8. Parese, D. M.: J. A. M. A. 175: 75, 1961. 9. Splitter, S. R.: Current Therap. Res. 2: 189, 1960. 10. Harsha, W. N.: J. Oklahoma M. A. 54: 12, 1961. 11. Beecher, H. K.: J. A. M. A. 159: 1602, 1955. 12. Orkin, L. R., Joseph, S. I., and Helrich, M.: New York J. Med. 57: 71, 1957. 13. Bross, I. D. J.: Fed. Proc. 13: 815, 1954. 2016 Forest Ave. San Jou. California