The PAIN (Pelvic Area Injection for Numbness) Study

Vaginal Laceration During Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05972681
• Other study ID #: 2023-14825
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: Clarissa P Diniz, MD
• Phone: 718-904-2767
• Email: cdiniz[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial with the objective 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >= 18 years old

• Healthy with a singleton pregnancy

• English or Spanish speaking

• Ongoing functioning epidural throughout the laceration repair

• 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

• Complaints of non-functional epidural

• Allergic to bupivacaine and/or epinephrine

• Epidural was a combined spinal-epidural (CSE)

• Received an epidural top-off < 3 hours from the perineal repair

• Experienced extreme pain at time of study consent (pain scale score > 3 on 0-10 scale)

Related Conditions & MeSH terms

• Lacerations
• Vaginal Laceration During Delivery

Intervention

Drug:
• Bupivacaine
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
• Epinephrine
Epinephrine (1:200,000) injected to the vaginal laceration site.

Other:
• Sham normal saline arm
10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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