Randomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain

doi:10.1016/S0029-7844(02)02339-6

Obstetrics & Gynecology

Volume 100, Issue 6, December 2002, Pages 1239-1243

Presented as a poster at the Annual Clinical Meeting of The American College of Obstetricians and Gynecologists; May 2002; Los Angeles, California.

https://doi.org/10.1016/S0029-7844(02)02339-6 Get rights and content

Abstract

OBJECTIVE:

To estimate the efficacy of lidocaine ointment in relieving pain after a vaginal delivery with an episiotomy or perineal laceration.

METHODS:

In a randomized, double-blind, placebo-controlled trial, 200 women received lidocaine ointment (n = 108) or a placebo (n = 92). Pain relief was assessed by the amount of ointment used (weight of jar before use − weight of jar after use), total number of pain pills used, and a pain questionnaire. The sample size was calculated using a β of .2 and an α of .05 with an expected reduction of other pain medications from an average use of six pills to four pills for the population.

RESULTS:

There was no significant difference in the amount of lidocaine versus placebo used for postpartum day 1 (5.1 g versus 4.0 g, respectively [P = .13]) or day 2 (3.7 g versus 2.6 g, respectively [P = .18]). Patients receiving lidocaine instead of the placebo showed no significant difference in the total amount of postpartum pain medications (6.3 versus 6.8 tablets, respectively [P = .53]), subjective pain parameters (P = .36), or satisfaction from ointment (P = .99). Patients with an episiotomy used more pain medications than those with a laceration (7.9 versus 5.6 tablets, respectively [P = .003]). Those with minor versus major lacerations required fewer pain pills (6.1 versus 10.8 tablets, respectively [P < .001]) and used less ointment (4.3 g versus 7.9 g, respectively [P = .02]) on the first postpartum day.

CONCLUSION:

Topical application of 5% lidocaine ointment was not effective in relieving episiotomy or perineal laceration pain.

Section snippets

Materials and methods

This randomized, placebo-controlled, double-blind study was conducted at the University Medical Center hospital affiliated with Texas Tech University Health Sciences Center. The study period extended from January 2000 to February 2002. All pregnant patients who had delivered vaginally with either an episiotomy or a perineal laceration were eligible to participate in the study. The institutional review board at our institution approved the study. Patients were excluded if they had history of

Results

The lidocaine and placebo groups were similar with respect to race, maternal age, parity, gestational age, weight, height, and neonatal birth weight (Table 1). There was also no significant difference in the admission cervical examination, duration of the three stages of labor, labor induction or augmentation, analgesia, type of vaginal delivery, method of placenta delivery, presence of episiotomy, degree of laceration, and the duration of postpartum stay (Table 2). Table 3 shows the nature and

Discussion

In this study, use of 5% lidocaine ointment applied to the perineum in the first and second postpartum days after an episiotomy or perineal laceration was not associated with improved pain relief. All three outcome measures (amount of ointment used, total number of pain medications, and pain questionnaires) did not show any significant difference between the lidocaine and placebo groups. This result supports others’ findings that showed that 2% lidocaine gel was not effective for perineal pain

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Cited by (22)

Comparison between lidocaine-prilocaine cream (EMLA) and mepivacaine infiltration for pain relief during perineal repair after childbirth: a randomized trial
2009, American Journal of Obstetrics and Gynecology
The purpose of this study was to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic infiltration in the reduction of pain during perineal suturing after childbirth.
Sixty-one women with either an episiotomy or a perineal laceration after vaginal delivery were assigned randomly to receive either the application of EMLA cream (n = 31) or infiltration with mepivacaine (n = 30) before perineal suturing. Primary outcome was pain during perineal repair.
Women in the EMLA group had lower pain scores than those in the mepivacaine group (1.7 ± 2.4 vs 3.9 ± 2.4; P = .0002). The proportion of women who needed additional anesthesia was similar in the 2 groups (3/30 vs 5/31; P = .71). A significantly higher proportion of women expressed satisfaction with anesthesia method in the EMLA group, compared with the mepivacaine group (83.8% vs 53.3%; P = .01)
EMLA cream appears to be an effective and satisfactory alternative to local anesthetic infiltration for the relief of pain during perineal repair.
Placement of Bupivacaine-soaked Spongostan in Episiotomy Bed Is Effective Treatment Modality for Episiotomy-associated Pain
2008, Journal of Minimally Invasive Gynecology
Citation Excerpt :
Some series have reported benefit in terms of pain reduction whereas others have reported no benefit. The inefficacy may be attributable to the lower concentration of anesthetics in addition to the site and method of its administration [11–14]. We soaked the Spongostan with 0.5% bupivacaine and kept it in the wound site.
To investigate the efficacy of placing bupivacaine-soaked Spongostan (Ferrosan, Soeborg, Copenhagen, Denmark) in episiotomy beds for relief of postpartum pain.
Randomized, controlled study (Canadian Task Force classification I).
University medical school.
Women with mediolateral episiotomy.
Patients were recruited and randomized into 2 groups by using a random number table. Group I (control group) received local lignocaine infiltration 1% up to 20 mL. For group II (Spongostan group), in addition to local lignocaine infiltration, bupivacaine-soaked Spongostan was placed in the episiotomy bed. All patients received routine postpartum perineal care in addition to the regular pain drugs (75 mg of diclofenac every 4 hours if needed). The primary outcome for the study was severity of pain, rated on a 10-cm visual analog scale from 0 to 10. Rating was recorded at 0, 1, 1.5, 2, 6, and 24 hours after delivery.
In all, 48 women were randomized to group I (local lignocaine alone) and 51 women to group II (local lignocaine plus Spongostan). The Spongostan and control groups were similar with respect to maternal age, parity, gestational age, maternal weight, and neonatal birth weight (p >.05; CI for difference: –2.6/10, 0.1/0.3, 0.3/0.7, 6.9/1.7, and –7/1.9, respectively). Episiotomy length (both vaginal and perineal) and episiotomy depth were higher in Spongostan group than control group (p <.05; 95% CI: –0.9/0, –0.8/–0.1, and –0.6/0, respectively). However, episiotomy reconstruction time of both groups was similar (p >.05; CI: 1.7/6.2). The pain score of Spongostan group was lower than control group and it was statistically significant at all time intervals (0, 1, 1.5, 2, 6, and 24 hours) between the Spongostan and control groups (p <.05; CI: 0.6/1.9, 1.1/2.4, 1.0/2.5, 0.9/2.4, 0.3/1.9, and 0.5/1.8, respectively). Postpartum total analgesic requirement (mg/person) again was significantly lower in the Spongostan group than control group (p <.01; CI: 0.1/0.4).
Placement of bupivacaine-soaked spongostan into the episiotomy bed resulted in decreased postpartum pain and drug requirement. It may be attributed to a higher drug concentration at episiotomy bed and prolonged drug effect.
Evaluation of postpartum perineal pain and dyspareunia-A prospective study
2008, European Journal of Obstetrics and Gynecology and Reproductive Biology
Citation Excerpt :
These complications can be potentially devastating for mothers and may affect relationships with their partner and bonding with the newborn child. Several pain scores have previously been used to assess perineal pain [3–14]. However, no study has used a validated pain score to assess perineal pain following vaginal birth complicated by obstetric anal sphincter injuries (OASIS).
Postpartum perineal pain and dyspareunia have been reported to affect 42% of women within the first 2 weeks after their first vaginal delivery. We aimed to determine the prevalence of dyspareunia and perineal pain using validated pain scores following accurate classification of perineal trauma according to the guidelines of the Royal College of Obstetricians and Gynaecologists.
Prospective study of women having their first vaginal delivery. All women had a perineal and rectal examination. Pain was assessed with a 4-point Verbal Rating Score and an 11-point visual analogue scale on day 1, day 5 and 2 months after delivery.
Two hundred and fifty-four women were invited and 95% participated. Ninety-two percent experienced perineal pain on day one, resolving in 88% (p < 0.001) at 2 months. Compared to an intact perineum or first degree tear significantly more women experienced perineal pain after a second, third or fourth degree tear. Forty percent resumed coitus within 2 months regardless of whether perineal trauma occurred or not. Five days after delivery, uncomplicated episiotomies resulted in more perineal pain than second degree tears.
Although perineal pain affected 92% of mothers, it resolved in the majority within 2 months of delivery. Obstetric anal sphincter injury is associated with more perineal pain than other perineal trauma. Spontaneous second degree tears cause less perineal pain than episiotomies. The 11-point visual analogue scale may be more sensitive than the 4-point Verbal Rating Score.
Decreased postpartum use of oral pain medication after a single dose of epidural morphine
2005, Regional Anesthesia and Pain Medicine
Pain after vaginal delivery may result from episiotomy, perineal laceration, or uterine involution. Many women have indwelling epidural catheters in place at delivery. We hypothesized that a small dose of epidural morphine would be an effective strategy for postpartum analgesia.
Eighty-one healthy parturients receiving epidural analgesia for labor were enrolled. Patients were randomized in double-blind fashion to 1 of 3 groups: all groups received a 4-mL volume of epidural solution consisting of saline (group 1, control), 1 mg (group 2), or 2 mg morphine (group 3) after vaginal delivery. During the first 24 hours postpartum, patients were evaluated for the amount of oral pain medication requested; visual analog scale scores for pain at rest and with movement; satisfaction with postpartum pain treatment; and opioid side effects including nausea, pruritus, urinary retention, and respiratory depression.
Patients who received 2 mg of epidural morphine used an average of 0.7 (0–-1, interquartile range) opioid-containing pain pills (acetaminophen with codeine or oxycodone) compared with 1.2 (0–2) in the 1-mg group and 1.9 (0–3) in the control group (P = .07). There was a statistically significant difference in oral drug usage between those who received epidural morphine and those who did not (P < .03). There were no differences in side effects except that at 12 hours postpartum there was an increase in Foley catheterization in the 1-mg morphine group (P = .007).
These results suggest that epidural morphine decreases the need for oral pain medication in the first 24 hours postpartum. No significant dose-dependent side effects were found.
A randomized controlled trial of pudendal nerve block for pain relief after episiotomy
2008, Anesthesia and Analgesia
Citation Excerpt :
Numerous treatments are used in clinical practice, including topical lidocaine ointment, oral and rectal analgesics, epidural opioids, therapeutic ultrasound, different methods of suturing and nonpharmacologic techniques, such as bath and ice packs.2–5,8–14 Topical anesthetics were not found to be effective in relieving episiotomy or perineal laceration pain.13,14 Codeine alone or in combination with acetaminophen is frequently used, but side effects (constipation, nausea, vomiting, and dizziness) limit its appeal.4
Pain from episiotomy or perineal tears during childbirth is associated with significant pain in the postpartum period. We performed this randomized, double-blind, controlled trial to investigate the efficacy of nerve stimulator-guided unilateral pudendal nerve block for pain relief after episiotomy.
Forty women who gave birth vaginally with mediolateral episiotomy were randomized to receive pudendal nerve block with 15 mL of either ropivacaine 7.5 mg/mL (pudendal group) or normal saline (control group) after repair of the episiotomy. Episiotomy pain was assessed with a visual analog scale at rest at 3, 6, 12, 24, and 48 h postepisiotomy and during activities (walking and sitting). Breakthrough pain (visual analog scale >30 mm) was treated with niflumic acid suppositories 700 mg every 12 h. The primary outcome variables were pain scores at rest and during activities over 48 h postpartum.
Demographic and obstetric characteristics were not different between groups. Successful pudendal nerve stimulation was achieved in all patients. Patients in the pudendal group reported significantly lower pain scores at rest than those in the control group at 3, 6, 12, 24, and 48 h after delivery (P < 0.05). They also reported better analgesia while sitting and walking (P < 0.05). Additional analgesia was required by three patients (15%) in the pudendal group versus 17 patients (85%) in the placebo group (P < 0.001).
This study demonstrates that nerve stimulator-guided unilateral pudendal nerve block with ropivacaine 7.5 mg/mL is associated with decreased pain and need for additional analgesics during the first 48 h postepisiotomy.
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View full text

Original researchRandomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain

Abstract

Section snippets

Materials and methods

Results

Discussion

J Urol

Pain

Pain

Ibuprofen versus placebo in the relief of post-episiotomy pain

Curr Med Res Opin

Aspirin and codeine in two postpartum pain models

Clin Pharmacol Ther

Epidural morphine pretreatment for postepisiotomy pain

Clin J Pain

Evaluation of two local anesthetic sprays for the relief of postepisiotomy pain

Curr Med Res Opin

Postpartum pain after vaginal deliveryA review of comparative analgesic trials

J Reprod Med

Original research
Randomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain