AzTrials
AzTrials

Complex Obstetric SurgeryPhase 4COMFORTNCT06925152

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

A Phase 4 study testing Bupivicaine intervention arm in people with Complex Obstetric Surgery and Perioperative Pain Management, run by University of Tennessee at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Bupivicaine intervention arm
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to May 2028
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 abdominal re-exploration surgery

Who cannot join

  • Planned general anesthesia
  • Supraumbilical skin incision
  • History of less than 3 cesarean deliveries if do not meet other inclusion criteria
  • 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
Show all 10Show fewer
  • Allergies to bupivacaine or oral analgesics
  • Patient preference
  • Planned cesarean hysterectomy
  • Administration of >4mg morphine to epidural

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael VanDillen Fellow physician, PI of study, MD contact

901-646-1321

mvandill@uthsc.edu

United States1 site, 1 recruiting
  • Regional One Health

    Memphis, Tennessee, 38103

    Michael Vandillen, MD, 314-619-1046, mvandill@uthsc.edu

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that targets the nerves innervating the abdominal wall, providing effective postoperative analgesia for patients undergoing various abdominal surgeries, including cesarean deliveries. The standard clinical practice for TAP blocks typically involves local anesthetics like bupivacaine, which, when administered in the appropriate plane, has been shown to reduce opioid consumption and improve pain management in the postoperative period.

Transversus abdominal plane (TAP) blocks, when administered intraoperatively, have demonstrated significant benefits in managing postoperative pain, especially in abdominal surgeries. Placing the TAP block during surgery provides early and prolonged analgesia, potentially reducing the need for postoperative opioids and improving recovery outcomes. A study completed in 2007 was one of the first to highlight the effectiveness of intraoperative TAP block placement in patients undergoing lower abdominal surgeries, showing a significant reduction in opioid consumption and better pain control. In the context of cesarean section, an intraoperative TAP block was shown to provide effective analgesia with a reduction in postoperative narcotic use. Similarly, a randomized trial in 2017 demonstrated that intraoperative TAP blocks significantly improved pain scores and reduced opioid consumption in patients undergoing colorectal surgeries. Furthermore, a study completed in 2014 found that performing TAP blocks intraoperatively for laparoscopic cholecystectomy patients resulted in lower visual analog scale (VAS) pain scores in the recovery room and reduced the incidence of postoperative nausea and vomiting. These findings underscore the advantages of intraoperative TAP block placement in enhancing postoperative analgesia across a variety of abdominal procedures.

Despite the widespread use of TAP blocks, there remains a gap in the literature regarding the effectiveness of bupivacaine TAP block use placed intraoperatively during more complex obstetric surgeries. Most existing studies focus on the use of TAP blocks for pain management after routine Pfannenstiel cesarean deliveries, with limited attention given to their role in cases involving higher-risk or more complicated obstetric situations, such as cesareans with significant intra-abdominal adhesions or other complications.

Although bupivacaine is commonly used in TAP blocks, its specific efficacy, optimal dosing, and potential benefits when placed intraoperatively in complex obstetric cases remain underexplored. The limited data in this area presents a critical gap in our understanding of how best to optimize pain management and improve surgical outcomes for women undergoing cesarean delivery, particularly in high-risk obstetric cases.

This blinded randomized controlled trial (RCT) seeks to address this gap by evaluating the effectiveness of intraoperative TAP blocks with bupivacaine during complex cesarean sections, focusing on the impact on postoperative analgesia and pain scores. By clarifying the role of bupivacaine in TAP blocks during complex obstetric surgery, this study aims to contribute valuable insights to the field of obstetric anesthesia and improve the perioperative experience for patients undergoing cesarean delivery.

Primary Objective: 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).

Primary Endpoint/Outcome: Pain medication requested, expressed as MMEs, from 0-24 and 0-48 hours after surgery.

Secondary Endpoint(s)/Outcome(s):

Total MME at 1-week after surgery Functional assessment of activities of daily life (ADL) at 1-week post operatively Number of unplanned postoperative visits within 6-months of surgery Geographic region of patients needing complex obstetric surgery.

Hypothesis: The investigators hypothesize that utilization of the TAP block will reduce MME requirements by 20% for patients who have undergone CD in the setting of COS.

Being tested
Bupivicaine intervention arm, Placebo arm
Keywords
Complex obstetric surgery, Perioperative pain management, cesarean delivery, postoperative pain control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivicaine intervention armDrug

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

  • Placebo armDrug

    Placebo group TAP block syringe will include 30mL normal saline

Study groups in NCT06925152
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorPlacebo group TAP (Transversus Abdominis Plane) block syringe will include 30mL normal saline.
Receives: Drug: Placebo arm
Intervention groupActive comparatorTAP (Transversus Abdominis Plane) blocks will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine.
Receives: Drug: Bupivicaine intervention arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain medication requested

    Total pain medication requested expressed in morphine milligram equivalents.

    Measured: Between 0-24 and 0-48 hours after surgery

Secondary outcomes (4)
  1. Total MME at one week after surgery

    Measured: One week postoperatively

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

    Measured: One week postoperatively

  3. Number of unplanned postoperative visits within six months of surgery

    Measured: Six months postoperatively

  4. Geographic region of patients needing complex obstetric surgery

    Heat maps to evaluate the distribution of patients across different demographic categories based on race and age within certain zip codes

    Measured: 24 months - through the duration of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start15 Jul 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-year (February 2025- February 2028) prospective double blinded randomized-control trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925152
Sponsor's protocol ID
COMFORT2025
Acronym
COMFORT
Status last verified
Oct 2026
First submitted
19 Mar 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17179269
  • 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.

    PubMed 22632762
  • Zhang, X., et al. (2017).

  • Kehlet, H., et al. (2014).

  • 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.

    PubMed 36378307
  • 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.

    PubMed 22907337
  • 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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in