The PAIN (Pelvic Area Injection for Numbness) Study

Study Overview
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Brief Summary
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The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in our institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The proposed trial is a two-arm, single-masked, prospective randomized superiority control trial. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.

Official Title
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A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia

Conditions
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Vaginal Laceration During Delivery

Intervention / Treatment
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* Drug: Bupivacaine and epinephrine
* Other: Sham normal saline arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years old Healthy with a singleton pregnancy English or Spanish speaking Ability to consent for themselves Exclusion Criteria: Women who underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage Multiple gestation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Anesthesia arm<br>Bupivicaine and Epinephrine | Drug: Bupivacaine and epinephrine<br>* Women in the bupivacaine and epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.<br>|
| Sham Comparator: Normal saline sham arm<br> | Other: Sham normal saline arm<br>* Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic | Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable. | Up to 24 hours after perineal laceration | 
| Maternal Satisfaction | Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) | 24 hours after perineal laceration | 
| Maternal Satisfaction | Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) | 48 hours after perineal laceration | 
| Maternal Satisfaction | Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) | 7 days after perineal laceration | 
| Pain score after injection at perineal laceration | Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where no pain is on the left end (0 cm) of the scale and the worst pain is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions | Immediately and 24 hours after perineal laceration |