Difficulty with enrollment

Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. 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 objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.

Perineal lacerations, the disruption of the skin, mucosa and sometimes muscles that happen commonly during vaginal birth secondary to stretching of the introitus; are present in more than 75% of all vaginal deliveries. These lacerations can be classified based on the location and depth (layers injured). However, the classification of these lacerations does not correlate necessarily with postpartum pain. Severe lacerations, as those compromising the external or internal anal sphincter are less common and associated with more postpartum pain.

It is common practice that only those lacerations causing bleeding, or distortion of normal pelvic anatomy are repaired. The repair of such lacerations at Montefiore Einstein is usually done using lidocaine for non-epiduralized patients; however, for patients with a functional epidural, no anesthetic agents are given locally to aid on long term pain control.

The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the 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.

Inclusion Criteria:

• Healthy with a singleton pregnancy
• English or Spanish speaking
• Ongoing functioning epidural throughout the laceration repair
• Multiparous or nulliparous
• Ability to consent for themselves

Exclusion Criteria:

• Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
• Have multiple gestations
• Complaints of non-functioning epidural
• Allergic to bupivacaine and/or epinephrine
• Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) < 3 hours from the perineal repair
• Experienced extreme pain at time of study consent (pain scale score > 3 on 0-10 scale)

From enrollment to end of follow-up, up to 7 days

Difficulty recruiting participants resulted in premature termination of the project and not able to collect enough data to determine effect of the intervention

Randomization will be blinded to the patient, the nurse carrying for the patient and providing the randomized, unlabeled syringe, the provider performing the perineal repair, the research team asking the maternal satisfaction questions, and the researcher analyzing the data. To assure blinding, the selection of the medication given, and the preparation of such medication will be performed by the labor and delivery anesthesia team. No one involved directly in the perineal laceration repair, or obtaining research information, nor the patient, will know what was injected. Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated. Urgent, immediate unblinding due to medical emergency may be authorized by the Investigator. When possible, the treatment assignment will be provided to the treating physician to maintain the blind for the Investigator and study staff.