A Phase 4 interventional study of Bupivacaine and Epinephrine in Vaginal Laceration During Delivery, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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.
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 causing bleeding, or distortion of normal pelvic anatomy are repaired. The repair of such lacerations at Montefiore Einstein is usually done using lidocaine for non-epiduralized patients; however, for patients with a functional epidural, no anesthetic agents are given locally to aid on long term pain control.
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.
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Exclusion Criteria:
Bupivicaine and Epinephrine
Drug: Bupivacaine · Drug: Epinephrine
Other: Sham normal saline arm
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
Epinephrine (1:200,000) injected to the vaginal laceration site.
10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Time to First Analgesic
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.
Time frame: Up to 24 hours after perineal laceration
Maternal Satisfaction
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.
Time frame: 24 hours, 48 hours, and 7 days after perineal laceration
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. No descriptive statistics were completed given the small sample size.
Time frame: 24 hours, 48 hours, and 7 days after perineal laceration
| Milestone | Local Anesthesia Arm | Normal Saline Sham Arm |
|---|---|---|
| Started | 2 | 1 |
| Completed | 1 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
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.
| minutes | Local Anesthesia Arm | Normal Saline Sham Arm |
|---|---|---|
| Time to First Analgesic | 141 ± NA | 342 ± NA |
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.
| score on a scale | Local Anesthesia Arm | Normal Saline Sham Arm |
|---|---|---|
| 24 hours | 3 ± NA | 1 ± NA |
| 48 hours | 2 ± NA | 1 ± NA |
| 7 days | 2 ± NA | 1 ± NA |
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.
| score on a scale | Local Anesthesia Arm | Normal Saline Sham Arm |
|---|---|---|
| 24 hours | 4 ± NA | 1 ± NA |
| 48 hours | 4 ± NA | 2 ± NA |
| 7 days | 2 ± NA | 0 ± NA |
Collected over From enrollment to end of follow-up, up to 7 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Local Anesthesia Arm | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Normal Saline Sham Arm | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| Mean | 34 (31 to 37) | 28 (28 to 28) | 32 (28 to 37) |
| Sex: Female, Male(Participants) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Local Anesthesia Arm | Normal Saline Sham Arm | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
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