Effect of Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively
研究概览
简要总结
This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. All participants will receive ITM as part of routine spinal anesthesia. The TAP group will receive an additional bilateral ultrasound-guided TAP block at the end of surgery, while the control group will not receive any additional block. Both groups will receive standardized postoperative analgesia with intravenous patient-controlled analgesia (IV PCA). The primary outcome is the quality of recovery at 24 hours postoperatively, measured using the validated Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Secondary outcomes include Numerical Rating Scale (NRS) pain scores, time to first breastfeeding, time to mobilization, time to hospital discharge, and total opioid consumption in the first 24 hours after surgery. Outcome assessors will be blinded to group allocation. The study aims to determine whether TAP block enhances functional recovery, reduces pain, and decreases analgesic requirements when used alongside ITM in cesarean delivery patients.
详细描述
Effective postoperative analgesia is essential for optimizing maternal recovery after cesarean delivery, promoting early mobilization, and supporting breastfeeding initiation. Spinal anesthesia with intrathecal morphine (ITM) is commonly used due to its long-lasting analgesia; however, it may not provide complete abdominal wall analgesia and can be associated with opioid-related side effects. The transversus abdominis plane (TAP) block is an ultrasound-guided regional anesthesia technique that provides somatic analgesia to the anterior abdominal wall by targeting the anterior rami of the thoracolumbar spinal nerves (T6-L1). When combined with ITM, TAP block may further improve recovery quality, reduce opioid requirements, and facilitate earlier return to daily activities.
In this prospective, assessor-blinded observational cohort study, all eligible patients undergoing elective cesarean delivery under spinal anesthesia at our institution will receive ITM as part of standard practice. Participants will be managed in two groups based on postoperative analgesia:
- TAP Group: Bilateral ultrasound-guided TAP block performed at the end of surgery in addition to ITM.
- Control Group: ITM only, without additional regional block.
Both groups will receive standardized postoperative analgesia via intravenous patient-controlled analgesia (IV PCA). Data will be collected prospectively, and the outcome assessor responsible for postoperative evaluation will be blinded to group allocation.
Primary Outcome:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-45 years
- •Singleton pregnancy
- •ASA physical status II-III
- •Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
- •Able to understand study procedures, provide written informed consent, and reliably use IV PCA
- •Able to complete ObsQoR-10-T assessments (with trained assistance if needed)
排除标准
- •Contraindication to spinal anesthesia or TAP block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- •Chronic opioid use or opioid/alfa-2 agonist intolerance
- •Severe preeclampsia, HELLP syndrome, significant hepatic or renal impairment
- •Urgent or emergent cesarean section (Category 1)
- •Cognitive impairment or communication difficulty preventing accurate assessment
- •Prior major abdominal surgery (other than previous cesarean delivery)
- •Body mass index (BMI) > 40 kg/m²
- •Major psychiatric illness (e.g., major depressive disorder, generalized anxiety disorder, psychosis) that may affect pain perception or quality of recovery
研究组 & 干预措施
ITM
Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care. No additional regional block will be performed. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group
干预措施: Spinal Anesthesia with Intrathecal Morphine Only (Other)
ITM + TAP
Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group
干预措施: Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block (Other)
结局指标
主要结局
Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively
时间窗: 24 hours after surgery
Total score on the validated Turkish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-T), measured by a blinded assessor. Scores range from 0 to 100, with higher scores indicating better recovery.
次要结局
- Total Opioid Consumption in 24 Hours(0-24 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores(0-24 hours postoperatively)
- Time to First Breastfeeding(Assessed from end of surgery to first breastfeeding attempt, up to 24 hours)
- Time to First Mobilization(Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively)
- Time to Hospital Discharge(Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively)
研究者
MEHMET GÖKHAN TAFLAN
Principal Investigator, Specialist in Anesthesiology
Samsun University