The PAIN (Pelvic Area Injection for Numbness) Study

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.

Timeline

Start

2025-04-08

Primary completion

2025-10-19

Completion

2025-10-19

Publications

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

Drugs

Indications

No indication recorded.