COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block

NCT06925152 | Recruiting Phase 4 FDA Drug

• 1 other identifier: COMFORT2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).

Conditions

Cesarean Delivery; Postoperative Pain Control; Complex Obstetric Surgery; Perioperative Pain Management

Keywords

Complex obstetric surgery; Perioperative pain management; cesarean delivery; postoperative pain control

Outcome Measures

Primary Outcomes (1)

• Pain medication requested

  Total pain medication requested expressed in morphine milligram equivalents.

  Between 24 and 48 hours after surgery

Secondary Outcomes (6)

• Total MME requested within first 24 hours postoperatively

  24 hours postoperatively

• Total MME requested within 48 hours postoperatively

  48 hours postoperatively

• Total MME at one week after surgery

  One week postoperatively

• Functional assessment of activities of daily life (ADL) at one week postoperatively

  One week postoperatively

• Number of unplanned postoperative visits within six months of surgery

  Six months postoperatively

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo group TAP (Transversus Abdominis Plane) block syringe will include 30mL normal saline.

Drug: Placebo arm

Intervention group

ACTIVE COMPARATOR

TAP (Transversus Abdominis Plane) blocks will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine.

Drug: Bupivicaine intervention arm

Interventions

Placebo arm DRUG

Placebo group TAP block syringe will include 30mL normal saline

Placebo group

Bupivicaine intervention arm DRUG

TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine

Intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient has a history of a least one of the following:
• Prior exploratory laparotomy
• History of non-obstetric open intra-abdominal surgery
• History of three or more prior cesarean deliveries
• History of intra-abdominal or pelvic adhesive disease
• History of abdominoplasty
• History of abdominal re-exploration surgery

You may not qualify if:

• Received general anesthesia
• History of chronic opioid use
• History of substance abuse (i.e. alcohol, methamphetamine/amphetamine, abuse of prescription opioid medication, or heroin use)
• History of chronic kidney disease
• Allergies to bupivacaine or oral analgesics
• Patient preference
• Cesarean hysterectomy
• Administration of ≥4mg morphine to epidural
• Loss to follow-up

Sponsors & Collaborators

• University of Tennessee: lead
• Regional One Health: collaborator

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (7)

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.

  PMID: 22632762 BACKGROUND

• Zhang, X., et al. (2017).

  BACKGROUND

• Kehlet, H., et al. (2014).

  BACKGROUND

• Garmi G, Parasol M, Zafran N, Rudin M, Romano S, Salim R. Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242203. doi: 10.1001/jamanetworkopen.2022.42203.

  PMID: 36378307 BACKGROUND

• 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.

  PMID: 22907337 BACKGROUND

• Ueshima, H., Higashijima, U., Matsumoto, M., & Imai, S. (2013). The effect of the volume of local anesthetic on the analgesic effect of transversus abdominis plane block in abdominal surgery. Journal of Anesthesia, 27(6), 650-655.

  BACKGROUND

Central Study Contacts

Michael VanDillen Fellow physician, PI of study, MD

CONTACT

314-619-1046; mvandill@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators plan to perform a double-blind study. Other than the investigational pharmacists, who do not have direct participant interaction, all study investigators and clinical care providers will be blinded to the allocation of participants. All clinical care will be per standard protocols for all participants. Patients will be unaware of their assignment. Data collectors/outcomes assessors will similarly collect all data and outcomes unaware of the assignment. All interim safety analyses and reports to the Data Safety Monitoring board will be blinded, with groups reported as A and B
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multi-year (February 2025- February 2028) prospective double blinded randomized-control trial

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 13, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)