Clinical trial NCT05972681: The PAIN (Pelvic Area Injection for Numbness) Study
Official title: A Randomized Controlled Trial of Bupivacaine With Epinephrine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia: The PAIN Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vaginal Laceration During Delivery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time to first analgesic
timeFrame: Up to 24 hours after perineal laceration
measure: Maternal Satisfaction
timeFrame: 24 hours after perineal laceration
measure: Maternal Satisfaction
timeFrame: 48 hours after perineal laceration
measure: Maternal Satisfaction
timeFrame: 7 days after perineal laceration
measure: Pain score after injection at perineal laceration
timeFrame: Immediately and 24 hours after perineal laceration
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Fatima Estrada, MD, FACOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Mahajan A, Derian A. Local Anesthetic Toxicity. StaPearls. Bookshelf ID: NBK499964. PMID: 29763139