The PAIN (Pelvic Area Injection for Numbness) Study

NCT ID: NCT05972681

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2026-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Vaginal Laceration During Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Local Anesthesia arm

Bupivicaine and Epinephrine

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.

Epinephrine

Intervention Type: DRUG

Epinephrine (1:200,000) injected to the vaginal laceration site.

Normal saline sham arm

Group Type: SHAM_COMPARATOR

Sham normal saline arm

Intervention Type: OTHER

10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Interventions

Bupivacaine

10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.

Intervention Type: DRUG

Epinephrine

Epinephrine (1:200,000) injected to the vaginal laceration site.

Intervention Type: DRUG

Sham normal saline arm

10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fatima Estrada, MD, FACOG

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alyssa M Yeung, MD

Role: CONTACT

ayeung@montefiore.org

574-329-8771

Fatima Estrada, MD, FACOG

Role: CONTACT

festrada@montefiore.org

718-904-2767

Facility Contacts

Alyssa M Yeung, MD

Role: primary

ayeung@montefiore.org

574-329-8771

References

Goh R, Goh D, Ellepola H. Perineal tears - A review. Aust J Gen Pract. 2018 Jan-Feb;47(1-2):35-38. doi: 10.31128/AFP-09-17-4333.

Reference Type: BACKGROUND

PMID: 29429318 (View on PubMed)

Butwick AJ, Bentley J, Wong CA, Snowden JM, Sun E, Guo N. United States State-Level Variation in the Use of Neuraxial Analgesia During Labor for Pregnant Women. JAMA Netw Open. 2018 Dec 7;1(8):e186567. doi: 10.1001/jamanetworkopen.2018.6567.

Reference Type: BACKGROUND

PMID: 30646335 (View on PubMed)

Dengler KL, Simpson KJ, Strauchon CJ, Shaddeau AK, Brooks DI, Gruber DD. A randomized controlled trial of liposomal bupivacaine for pain following obstetrical laceration. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100115. doi: 10.1016/j.ajogmf.2020.100115. Epub 2020 Apr 15.

Reference Type: BACKGROUND

PMID: 33345866 (View on PubMed)

Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management: ACOG Clinical Consensus No. 1. Obstet Gynecol. 2021 Sep 1;138(3):507-517. doi: 10.1097/AOG.0000000000004517.

Reference Type: BACKGROUND

PMID: 34412076 (View on PubMed)

Schinkel N, Colbus L, Soltner C, Parot-Schinkel E, Naar L, Fournie A, Granry JC, Beydon L. Perineal infiltration with lidocaine 1%, ropivacaine 0.75%, or placebo for episiotomy repair in parturients who received epidural labor analgesia: a double-blind randomized study. Int J Obstet Anesth. 2010 Jul;19(3):293-7. doi: 10.1016/j.ijoa.2009.11.005. Epub 2010 Jun 2.

Reference Type: BACKGROUND

PMID: 20627696 (View on PubMed)

Deshpande JP, Saundattikar GY. Lignocaine Versus Ropivacaine Infiltration for Postpartum Perineal Pain. Anesth Essays Res. 2017 Apr-Jun;11(2):300-303. doi: 10.4103/0259-1162.177191.

Reference Type: BACKGROUND

PMID: 28663610 (View on PubMed)

Mahajan A, Derian A. Local Anesthetic Toxicity. StaPearls. Bookshelf ID: NBK499964. PMID: 29763139

Reference Type: BACKGROUND

Other Identifiers

2023-14825

Identifier Type: -

Identifier Source: org_study_id