Trial Outcomes & Findings for The PAIN (Pelvic Area Injection for Numbness) Study (NCT NCT05972681)

Last Updated: 2026-05-27

Results Overview

Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities. Participants will rate their ability to carry out these activities at 24 hours, 48 hours and 7 days using a 5-point scale (1 = very good; 2 = good; 3 = neutral; 4 = poor; or 5 = very poor) such that lower scores are indicative of increased ability to execute daily living activities. No descriptive statistics were completed given the small sample size.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

24 hours, 48 hours, and 7 days after perineal laceration

Results posted on

2026-05-27

Participant Flow

From the time of consent to assignment to an arm, patients delivered. 19 patients were consented; however, 15 patients were not enrolled as they did not meet inclusion criteria after delivery and were not eligible for the study. In addition, 1 patient was not enrolled/randomized due to poorly functioning epidural. 3 patients were enrolled. Of the 3 patients who were randomized, 1 patient did not have the follow-up survey administered properly. Therefore, only 2 patients were evaluated.

Participant milestones

Participant milestones
Measure	Local Anesthesia Arm Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Overall Study STARTED	2	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Local Anesthesia Arm Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Overall Study Protocol Violation	1	0

Baseline Characteristics

The PAIN (Pelvic Area Injection for Numbness) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Anesthesia Arm n=2 Participants Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm n=1 Participants Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=51 Participants	1 Participants n=14 Participants	3 Participants n=65 Participants
Age, Categorical >=65 years	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Age, Continuous	34 years n=51 Participants	28 years n=14 Participants	32 years n=65 Participants
Sex: Female, Male Female	2 Participants n=51 Participants	1 Participants n=14 Participants	3 Participants n=65 Participants
Sex: Female, Male Male	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Asian	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Black or African American	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) White	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=51 Participants	1 Participants n=14 Participants	3 Participants n=65 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=51 Participants	1 Participants n=14 Participants	2 Participants n=65 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=51 Participants	0 Participants n=14 Participants	1 Participants n=65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Region of Enrollment United States	2 participants n=51 Participants	1 participants n=14 Participants	3 participants n=65 Participants

PRIMARY outcome

Timeframe: Up to 24 hours after perineal laceration

The average time to first analgesic (TFA), in minutes, will be evaluated as the duration interval from injection to administration of the first analgesic, as applicable.

Outcome measures

Outcome measures
Measure	Local Anesthesia Arm n=1 Participants Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm n=1 Participants Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Time to First Analgesic	141 minutes Standard Deviation NA Standard Deviation (SD) could not be calculated due to a sample size of 1. (N=1)	342 minutes Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)

PRIMARY outcome

Timeframe: 24 hours, 48 hours, and 7 days after perineal laceration

Outcome measures

Outcome measures
Measure	Local Anesthesia Arm n=1 Participants Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm n=1 Participants Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Maternal Satisfaction 24 hours	3 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	1 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)
Maternal Satisfaction 48 hours	2 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	1 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)
Maternal Satisfaction 7 days	2 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	1 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)

PRIMARY outcome

Timeframe: 24 hours, 48 hours, and 7 days 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. No descriptive statistics were completed given the small sample size.

Outcome measures

Outcome measures
Measure	Local Anesthesia Arm n=1 Participants Bupivicaine and Epinephrine 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.	Normal Saline Sham Arm n=1 Participants Sham normal saline arm: 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Pain Score After Injection at Perineal Laceration 24 hours	4 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	1 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)
Pain Score After Injection at Perineal Laceration 48 hours	4 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	2 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)
Pain Score After Injection at Perineal Laceration 7 days	2 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)	0 score on a scale Standard Deviation NA SD could not be calculated due to a sample size of 1. (N=1)

Adverse Events

Local Anesthesia Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Sham Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alyssa Yeung, House Staff - Maternal-Fetal Medicine

Montefiore Medical Center

Phone: 5743298771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place