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Randomized Trial of Lidocaine Ointment Versus Placebo for the Treatment of Postpartum Perineal Pain

From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada; Maternal Fetal Medicine, Bellin Health Hospital Center, Green Bay, Wisconsin; and Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center, Lubbock, Texas.

Address reprint requests to: Vatche A. Minassian, MD, 33 Davisville Avenue, #415, Toronto, Ontario M4S 2Y9, Canada; E-mail: vatche.minassian{at}utoronto.ca.

	ABSTRACT

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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 ß of .2 and an ß 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.

Pain related to episiotomy and laceration in the immediate postpartum period has been traditionally treated with oral medications including nonsteroidals,¹ intravenous narcotics,² epidural narcotics,³ and local anesthetic spray.⁴ Nonsteroidal anti-inflammatory drugs like ibuprofen have been shown to be better analgesics than acetaminophen, and similar to codeine for episiotomy pain.^2,5 Other local measures include hazel compresses and warm sitz baths. In fact, some authors recommend cold sitz baths because of the decreased free nerve endings’ excitability and muscle spasm.⁶

Lidocaine ointment is a local anesthetic used by dermatologists for treatment of superficial skin conditions,⁷ neurologists for the treatment of postherpetic neuralgia,⁸ and dentists for oral mucosa pain.⁹ It is also reported in the urology literature during the introduction of the cystoscope.¹⁰ In obstetrics, application of lidocaine jelly on the perineum in the second stage of labor has been shown to lessen pain perception in the immediate postpartum period.¹¹ The advantages of using topical lidocaine include its localized action with negligible systemic absorption,¹² ease of administration, and self-application by the patient. The purpose of our study was to evaluate whether lidocaine ointment would be a useful replacement or adjunct to the standard medications used for the treatment of postepisiotomy or perineal laceration pain.

	MATERIALS AND METHODS

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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 adverse reactions to local anesthetics or lidocaine, cardiac disease, class C diabetes or more on the White classification, or neurological disease affecting the lower extremities.

Patients with an episiotomy or a first, second, third, or fourth degree perineal laceration were recruited in the immediate peripartum period by the labor and delivery residents. Although a record of the recruitment success rate was not kept, most patients agreed to participate in the study. Periurethral and vaginal wall lacerations were classified as second degree lacerations. Cervical lacerations were not considered to be a cause of perineal pain and were not included in this study. In the overall analysis, an episiotomy was classified as a second degree laceration. All episiotomies except one were performed as median episiotomies. When a patient sustained more than one laceration, the one with the highest degree was considered.

Patients were randomized to receive either a 20-g jar of 5% lidocaine ointment or a 20-g placebo jar (with the same base, consistency, and color). All patients received the routine postpartum perineal care in addition to the regular pain medications as needed. Randomization was performed using a random number table. Each number on the table had a corresponding labeled lidocaine or placebo ointment in the pharmacy. Once a patient signed the study consent, we chose the next number on the random number table and sent an order to the pharmacy where the corresponding jar was dispensed. Patients and medical personnel, including the investigators, were masked to the contents of the jar.

The nursing personnel gave the jar to the appropriate patient, who was instructed to apply the ointment on the involved area (episiotomy or laceration) of the perineum at a frequency not to exceed 4 hours. Twenty-four hours after use, and if the patient stayed for another postpartum day, the jar was replaced by another, similar jar containing the same ointment.

The primary outcome measure was the amount of pain relief obtained from using the ointment during the first 2 postpartum days. This outcome was measured by assessing the amount of ointment used (weight of the jar before use – weight of the jar after use) and the total number of pain medication pills taken by the patient. All jars were weighed by the same investigator (SDP) using the same scale. A pain questionnaire with visual and linear analogue scales^13,14 was given by the research nurse to all patients to fill in the morning of postpartum day 1 or 2. The questionnaires were picked up by the unit nurse or the research nurse before discharge. The visual scale ranged from 0 to 5 (0 = no pain, 5 = worst pain), and the linear rating scale ranged from 0 to 10 (0 = no pain, 10 = worst pain). Both scales were used to measure the difference in pain perception by patients before and after ointment use.

The total number of patients needed was 200. This figure was calculated using a ß value of .20 and an ß value of .05, with an expected reduction in the use of other pain medications from an average of six pills and standard deviation of 5 (calculated retrospectively from chart reviews before initiation of this study) to an average of four pills. Analysis of data was performed using the SPSS statistical package (SPSS, Chicago, IL). For continuous variables, data were analyzed using the unpaired t test, the Pearson ² test, or the analysis of variance test. For noncontinuous variables, the Mann-Whitney U test and nonparametric statistical analyses were performed. A P value of less than .05 was considered statistically significant.

	RESULTS

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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 amount of pain medications taken by the patients. There was no significant difference either in the amount of ointment used or in the total number of postpartum pain medications taken between the lidocaine and placebo groups (Table 4). Analysis of the pain questionnaires did not reveal any significant difference in the pain parameters or satisfaction from the ointment (Table 5).

Seventy-six patients had an episiotomy, and 110 had a laceration. Those with an episiotomy used more pain medications than those with a laceration (7.9 ± 0.4 versus 5.6 ± 0.6 tablets, respectively [P = .003]). However, analysis of the pain questionnaires in the subset of patients with only an episiotomy did not reveal any lessening of pain perception in the lidocaine and placebo groups, reported as median [minimum–maximum], on the visual scale (2 [0–8] versus 3 [0–8], respectively [P = .36]), the linear scale (1 [0–5] versus 1 [0–4], respectively [P = .13]), and satisfaction from ointment (2 [1–7] versus 2 [1–7], respectively [P = .93]).

One hundred seventy-one patients had a minor laceration (first or second degree perineal laceration, periurethtral laceration, or episiotomy), and 15 patients had a major laceration (third or fourth degree laceration or episiotomy extension). Relative to those with a major laceration, patients with a minor laceration required fewer pain medications (6.1 ± 0.4 versus 10.8 ± 1.5 tablets, respectively [P <.001]), and used less of the ointment on postpartum day 1 (4.3 ± 0.4 g versus 7.9 ± 1.9 g, respectively [P = .02]) and postpartum day 2 (2.9 ± 0.4 g versus 6.9 ± 2.3 g, respectively [P = .009]). However, analysis of the subset of patients with a minor laceration did not reveal any significant difference in the amount of ointment used on postpartum day 1 (4.5 ± 0.6 g versus 4.0 ± 0.5 g [P = .39]) or in the total number of postpartum pain pills (5.8 ± 0.5 versus 6.5 ± 0.5 tablets [P = .39]) between the lidocaine and placebo groups, respectively. This similarity was also true for the subset of patients with a major laceration (data not shown).

The complications from using the ointment were limited to only two patients, one from each group. They both complained of perineal irritation and itching while using the ointment.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
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 relief during the first postpartum day, although they suggested some effect during the second postpartum day.¹⁵ Other authors have used topical pramoxine and hydrocortisone foam and found no advantage over simple aqueous foam in the treatment of postpartum episiotomy discomfort.¹⁶

Collins et al¹¹ used 2% lidocaine gel during the second stage of labor and showed that there was decreased pain perception in the immediate postpartum period. Others⁴ showed that 5% lignocaine spray was effective for the immediate relief of postepisiotomy pain. However, the significance in pain perception achieved was based only on subjective pain questionnaires,^4,11 and the studies included only primiparous patients.⁴ Our study involved a larger population with patients of any parity, and both subjective and objective outcome measures were used.

Our study suggests that patients who had a major laceration had more pain in their perineum because they required more pain medications, and used more of the ointment than those who had a minor laceration. Our findings also support previously published studies that have shown that patients with an episiotomy have more pain than those without one.¹⁷ However, though major laceration and episiotomy patients used more pain pills than minor laceration and no episiotomy patients, respectively, application of the lidocaine ointment did not seem to help in relieving their pain any more than it did in the placebo group.

Postpartum patients typically also complain of pain unrelated to the perineum, such as uterine cramping and back pain. Harrison and Brennan⁴ have shown that patients who breast-feed their newborn babies respond less to analgesia than those who do not breast-feed. Although patients may have required additional pain medications for pain unrelated to their episiotomy or laceration, the adequate randomization in our study would have controlled for this confounder.

Another confounding variable in our study was the fact that patients were asked to apply the ointment on the perineum with their bare fingers. Although the consistency, color, and weight of the lidocaine and placebo jars were identical, patients using the lidocaine ointment may have realized they had the medication jar by feeling numbness in their fingers. In addition, there were no timed reminders by the nursing personnel, and no objective quantitative means to allow patients similar applications every time they used the ointment. This could have created the variation in the amount of ointment used among the patients. Our goal was to study whether lidocaine ointment could be an easy, effective, and self-administered analgesia for the patient in the immediate postpartum period. Based on our findings, lidocaine ointment is no more effective than a placebo in relieving episiotomy or postpartum perineal laceration pain.

	Footnotes

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

PII S0029-7844(02)02339-6

Received May 2, 2002. Received in revised form July 13, 2002. Accepted July 25, 2002.

	REFERENCES

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1. Taina E. Ibuprofen versus placebo in the relief of postepisiotomy pain. Curr Med Res Opin 1981;7:423–8.[Medline]

2. Bloomfield SS, Barden TP, Mitchell J. Aspirin and codeine in two postpartum pain models. Clin Pharmacol Ther 1976;20:499–503.[Medline]

3. Niv D, Wolman I, Yashar T, Varrassa G, Rudick V, Geller E. Epidural morphine pretreatment for postepisiotomy pain. Clin J Pain 1994;10:319–23.[Medline]

4. Harrison RF, Brennan M. Evaluation of two local anesthetic sprays for the relief of postepisiotomy pain. Curr Med Res Opin 1987;10:364–9.[Medline]

5. Windle ML, Booker LA, Rayburn WF. Postpartum pain after vaginal delivery: A review of comparative analgesic trials. J Reprod Med 1989;34:891–5.[Medline]

6. Droegemueller W. Cold sitz baths for relief of postpartum perineal pain. Clin Obstet Gynecol 1980;23:1039–43.[Medline]

7. Rubin MG. The efficacy of a topical lidocaine/prilocaine anesthetic gel in 35% trichloracetic acid peels. Dermatol Surg 1995;21:223–5.[Medline]

8. Rowbotham MC, Davies PS, Fields HL. Topical lidocaine gel relieves postherpetic neuralgia. Ann Neurol 1995;37: 246–53.[Medline]

9. Svensson P, Bjerring P, Arendt-Nielsen L, Kaaber S. Hypoalgesic effect of EMLA and lidocaine gel applied on human oral mucosa: Quantitative evaluation by sensory and pain thresholds to argon laser stimulation. Anesth Prog 1993;39:4–8.[Medline]

10. Stein M, Lubetkin D, Taub HC, Skinner WK, Haberman J, Kreutzer ER. The effects of intraurethral lidocaine anesthetic and patient anxiety on pain perception during cystoscopy. J Urol 1994;151:1518–21.[Medline]

11. Collins MK, Porter KB, Brook E, Johnson L, Williams M, Jevitt CM. Vulvar application of lidocaine for pain relief in spontaneous vaginal delivery. Obstet Gynecol 1994;84: 335–7.[Abstract/Free Full Text]

12. Johnstone RE, Wax MK, Bishop DJ, Chafin JB. Large doses of topical lidocaine during microvascular surgery are not associated with toxic blood concentrations. Anesthesiology 1995;82:593–6.[Medline]

13. Scott J, Huskisson EC. Graphic representation of pain.Pain 1976;2:175–84.[Medline]

14. Price DP, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 1994;56: 217–26.[Medline]

15. Corkill A, Lavender T, Walkinshaw SA, Alfirevic Z. Reducing postnatal pain from perineal tears by using lignocaine gel: A double-blind randomized trial. Birth 2001;28: 22–7.[Medline]

16. Greer IA, Cameron AD. Topical pramoxine and hydrocortisone foam versus placebo in relief of post partum episiotomy symptoms and wound healing. Scott Med J 1984;29:104–6.[Medline]

17. Larsson PG, Platz-Christensen JJ, Bergman B, Wallstersson G. Advantage or disadvantage of episiotomy compared with spontaneous perineal laceration. Gynecol Obstet Invest 1991;31:213–6.[Medline]

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