A Randomized Controlled Trial of Bupivacaine With Epinephrine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia: The PAIN Trial
Montefiore Medical Center
Summary
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.
Description
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 ca…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * \>= 18 years old * 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 * Vaginal delivery was complicated by a postpartum hemorrhage * Have multiple gestations * Complaints of non-functional epidural * Allergic to bupivacaine and/or epinephrine * Epidural was a combined spinal-epidural (CSE) * Receiv…
Interventions
- DrugBupivacaine
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
- DrugEpinephrine
Epinephrine (1:200,000) injected to the vaginal laceration site.
- OtherSham normal saline arm
10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Location
- Montefiore Medical CenterThe Bronx, New York