The PAIN (Pelvic Area Injection for Numbness) Study

Launched by MONTEFIORE MEDICAL CENTER · Jul 25, 2023

Keywords

ClinConnect Summary

The PAIN Study is researching how to help women who experience pain from vaginal lacerations during delivery. Many women who give birth vaginally suffer from tears in the perineum (the area between the vagina and anus), which can lead to severe pain after the numbness from an epidural wears off. This study aims to find out if injecting a local pain relief medicine (bupivacaine with epinephrine) directly into the laceration can provide longer-lasting pain relief and improve overall satisfaction compared to a placebo (saline injection).

To be eligible for the study, participants must be at least 18 years old, healthy, and able to speak English or Spanish. They should have a working epidural during their delivery and have experienced a second-degree vaginal tear. Women who have had certain complications or specific medical conditions will not be able to participate. If someone decides to join, they will receive either the pain relief injection or the placebo, and the study will check their pain levels and satisfaction 24 hours later. This trial is currently recruiting participants, and it aims to make recovery after childbirth easier and more comfortable for new mothers.

Gender

FEMALE

Eligibility criteria

• 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)
• • 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)