Intraoperative TAP Block After Repeat Cesarean

Post-operative Pain Clinical Trial

Official title:

Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393908
• Other study ID #: STUDY00000407
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Gianna Wilkie, MD
• Phone: 508-334-9189
• Email: Gianna.Wilkie[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Description:

Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.

• Pregnancy and delivery care obtained at UMass Memorial Medical Center

• Patients able to provide written informed consent

• English, Spanish, or Portuguese-speaking patients

Exclusion Criteria:

• Participants who are under the age of 18 years

• Active labor.

• Baseline pain score > 6.

• Unable to provide informed consent.

• Prisoners will be excluded from this research.

• Narcotic use in the 2 weeks prior to delivery.

• Active substance abuse.

• Inability to take narcotic analgesia.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• TAP Block Group
Participants will receive a surgeon administered TAP block.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

References & Publications (6)

Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis. Br J Anaesth. 2012 Nov;109(5):679-87. doi: 10.1093/bja/aes279. Epub 2012 Aug 19. — View Citation

Kupiec A, Zwierzchowski J, Kowal-Janicka J, Gozdzik W, Fuchs T, Pomorski M, Zimmer M, Kubler A. The analgesic efficiency of transversus abdominis plane (TAP) block after caesarean delivery. Ginekol Pol. 2018;89(8):421-424. doi: 10.5603/GP.a2018.0072. — View Citation

Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1. — View Citation

Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24. — View Citation

Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. — View Citation

Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Narcotic Use in Morphine Equivalents	Daily Narcotic Use in Morphine Equivalents	From time of surgery through postpartum day 4
Secondary	Time to first administered narcotic (oral or parental)	Time to first administered narcotic (oral or parental) post cesarean delivery	From time of surgery through postpartum day 4
Secondary	Daily Average Pain Score	Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain	From time of surgery through postpartum day 4
Secondary	Daily Maximum Pain Score	Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain	From time of surgery through postpartum day 4
Secondary	Time to First Ambulation	Time to First Ambulation post cesarean delivery	From time of surgery through postpartum day 4
Secondary	Time to First Solid Food	Time to First Solid Food	From time of surgery through postpartum day 4