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临床试验/NCT06925152
NCT06925152招募中4 期

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

University of Tennessee1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月15日最近更新:
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
120
试验地点
1
主要终点
Pain medication requested

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Received general anesthesia
  • 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
  • Allergies to bupivacaine or oral analgesics
  • Patient preference
  • Cesarean hysterectomy
  • Administration of ≥4mg morphine to epidural
  • Loss to follow-up

研究组 & 干预措施

Placebo group

Placebo Comparator

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

干预措施: Placebo arm (Drug)

Intervention group

Active Comparator

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

干预措施: Bupivicaine intervention arm (Drug)

结局指标

主要结局

Pain medication requested

时间窗: Between 24 and 48 hours after surgery

Total pain medication requested expressed in morphine milligram equivalents.

次要结局

  • 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)
  • Geographic region of patients needing complex obstetric surgery(24 months - through the duration of the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael B VanDillen MD

Principal Investigator

University of Tennessee

研究点 (1)

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