The PAIN (Pelvic Area Injection for Numbness) Study

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972681

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Laceration During Delivery	Drug: Bupivacaine with epinephrine arm Other: Sham normal saline arm	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine with epinephrine arm	Drug: Bupivacaine with epinephrine arm Women in the bupivacaine with epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.
Sham Comparator: Normal saline sham arm	Other: Sham normal saline arm Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Arm

Intervention/Treatment

Experimental: Bupivacaine with epinephrine arm

Drug: Bupivacaine with epinephrine arm

Women in the bupivacaine with epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.

Sham Comparator: Normal saline sham arm

Other: Sham normal saline arm

Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Outcome Measures

Primary Outcome Measures

Time to first analgesic [Up to 24 hours after perineal laceration]
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.
Maternal Satisfaction [24 hours after perineal laceration]
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)
Pain score after injection at perineal laceration [Immediately and 24 hours after 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT05972681

Other Study ID Numbers:

2023-14825

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lacerations

Epinephrine

Bupivacaine

Study Results

No Results Posted as of Aug 2, 2023