Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption in the First 24 Hours Postoperatively
研究概览
简要总结
This prospective, randomized, double-blind study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Secondary outcomes include postoperative pain scores, time to first analgesic request, shoulder pain, postoperative nausea and vomiting, and block-related complications.
详细描述
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and postoperative outcome assessors will be blinded to group allocation. The regional block will be performed after induction of general anesthesia to maintain participant blinding. Postoperative pain assessments and data collection will be conducted by investigators who are unaware of the assigned intervention. The anesthesiologist performing the block will not be involved in postoperative outcome assessment.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Ability to understand the study protocol and provide written informed consent -
排除标准
- •Refusal to participate
- •Known allergy or contraindication to local anesthetic agents
- •Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
- •Infection at the planned injection site
- •Body mass index (BMI) > 35 kg/m²
- •Chronic opioid use or opioid dependence
- •Chronic pain syndromes requiring regular analgesic treatment
- •Severe hepatic, renal, or cardiac dysfunction
- •Pregnancy or breastfeeding
- •Inability to communicate or assess pain using the Numerical Rating Scale (NRS)
研究组 & 干预措施
Erector Spinae Plane Block
Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
干预措施: Erector Spinae Plane Block (Procedure)
Subcostal TAP Block
Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
干预措施: Subcostal Transversus Abdominis Plane Block (Procedure)
结局指标
主要结局
Total Opioid Consumption in the First 24 Hours Postoperatively
时间窗: Within 24 hours after surgery
Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
次要结局
未报告次要终点
研究者
Bekir Suat Kürkçüoğlu
medical doctor
Gaziantep City Hospital