Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cumulative Postoperative Tramadol Consumption During the First 24 Hours
研究概览
简要总结
This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block.
Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic.
After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.
详细描述
This was a prospective, single-center, randomized, parallel-group controlled study conducted in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Eligible participants were 18 to 65 years of age and had an American Society of Anesthesiologists physical status classification of I to III.
After providing written informed consent, participants were randomly assigned using a sealed-envelope method to one of two study groups. Participants in the first group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. Participants in the second group received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. Both blocks were performed with 0.25% bupivacaine after removal of the gallbladder and before extubation.
General anesthesia and perioperative multimodal analgesia were standardized for both groups. Following surgery, all participants received intravenous patient-controlled analgesia with tramadol. Additional paracetamol was administered when the Visual Analog Scale pain score was 4 or higher. Ondansetron was administered when postoperative nausea or vomiting was present.
The primary outcome was cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes included Visual Analog Scale pain scores, patient-controlled analgesia demand, tramadol consumption at individual assessment times, additional analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, and block-related complications. Outcomes were assessed upon arrival in the post-anesthesia care unit and at 30 minutes and 2, 3, 6, and 24 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia
- •American Society of Anesthesiologists physical status I to III
- •Body mass index below 35 kg/m²
- •International Normalized Ratio and platelet count within the institutional reference ranges
- •Liver and renal function test results within the institutional reference ranges
- •Provision of written informed consent
排除标准
- •Bleeding diathesis
- •Known allergy to local anesthetics
- •Infection or inflammation at the planned block application site
- •Gallbladder perforation
- •Known neurological disease
- •American Society of Anesthesiologists physical status IV or higher
- •Long-term medication use for chronic pain
- •Advanced liver or renal failure
- •Previous abdominal surgery or abdominal trauma
- •Use of any opioid medication within 24 hours before surgery
- •Pregnancy
- •Refusal to participate
- •Intraoperative conversion from laparoscopic to open surgery
研究组 & 干预措施
Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach
After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. The block was performed at the inferior surface of the 10th costal cartilage using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms.
干预措施: Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (Procedure)
Bilateral Erector Spinae Plane Block
After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. The local anesthetic was injected between the erector spinae muscle and the transverse process using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms.
干预措施: Bilateral Ultrasound-Guided Erector Spinae Plane Block (Procedure)
结局指标
主要结局
Cumulative Postoperative Tramadol Consumption During the First 24 Hours
时间窗: From arrival in the post-anesthesia care unit through 24 hours after surgery
The total amount of tramadol delivered through intravenous patient-controlled analgesia was calculated for each participant. The patient-controlled analgesia device was programmed to deliver a 15 mg tramadol bolus with a 15-minute lockout interval. Tramadol consumption recorded during the postoperative observation periods was summed and reported in milligrams. The standardized intraoperative tramadol dose administered to all participants was not included in this outcome.
次要结局
- Postoperative Pain Intensity Assessed Using the Visual Analog Scale(At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery)
- Patient-Controlled Analgesia Demand Count(At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery)
- Tramadol Consumption at Individual Postoperative Assessment Times(At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery)
- Requirement for Additional Postoperative Analgesia(From post-anesthesia care unit arrival through 24 hours after surgery)
- Postoperative Nausea and Vomiting Score(At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery)
- Requirement for Rescue Antiemetic Medication(From post-anesthesia care unit arrival through 24 hours after surgery)
- Incidence of Block-Related Complications(From block administration through 24 hours after surgery)
研究者
Yasemin Yazman Arınç
MD
Saglik Bilimleri Universitesi