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临床试验/NCT07393763
NCT07393763已完成不适用

Effectiveness of Rectus Sheath Block as an Adjunct to General Anesthesia for Postoperative Pain and Inflammation in Patients Undergoing Midline Incision Laparotomy at RSUP Sanglah

Udayana University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Postoperative Pain Intensity (Numeric Rating Scale, NRS)

研究概览

简要总结

This study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB with local anesthetic (bupivacaine 0.25%). After surgery, pain will be assessed using the Numeric Rating Scale (NRS) at 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. The study will also compare the time to first opioid request, total opioid use during the first 24 hours after surgery, and changes in inflammation measured by the neutrophil-to-lymphocyte ratio (NLR). The goal is to determine whether RSB can reduce postoperative pain and opioid requirements and help limit postoperative inflammatory response.

详细描述

This is a double-blind randomized controlled trial conducted in adult patients (18-64 years) undergoing midline incision laparotomy under general anesthesia at Sanglah Hospital. Eligible participants are enrolled consecutively and randomized using permuted block randomization with sealed envelopes into two parallel groups:

Group A (Control): General anesthesia without rectus sheath block.

Group B (Intervention): General anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (RSB) using bupivacaine 0.25%.

Anesthetic management is standardized. Patients receive IV midazolam 0.02 mg/kg as premedication. Induction is performed with propofol 1-2 mg/kg and fentanyl 2 mcg/kg, followed by atracurium 0.5 mg/kg for intubation. Maintenance includes pressure-controlled ventilation (FiO₂ 40%, flow 2 L/min) and propofol infusion 50-150 mcg/kg/min. Intraoperative analgesia is supplemented with fentanyl 0.5 mcg/kg every 45 minutes. Hemodynamics are maintained within 20% of baseline.

RSB technique (Group B): After intubation, the abdominal skin is disinfected. A linear ultrasound probe is placed lateral to the umbilicus to identify the rectus abdominis muscle and posterior rectus sheath. Using an in-plane approach, a 50 mm needle is advanced from lateral to medial until the needle tip lies between the rectus abdominis muscle and posterior rectus sheath. After negative aspiration, 20 mL of bupivacaine 0.25% is injected as a single-shot on one side with aspiration every 3 mL, visualizing separation of the rectus muscle from the posterior sheath. The procedure is then repeated on the contralateral side (bilateral block).

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants were blinded to group assignment. Postoperative pain assessments (NRS) and outcome data collection were performed by an independent assessor who was blinded to allocation. Randomization codes were kept in sealed envelopes and were not disclosed to the assessor until data collection was completed. Data analysis was performed using coded group labels.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-64 years.
  • Patients undergoing midline laparotomy incision (incision extending above to below the umbilicus) for digestive, obstetric, or oncology cases (corresponding to T7-T12 dermatomes) under general anesthesia.
  • ASA physical status I-III.
  • Body mass index (BMI) 18.5-30 kg/m².
  • Willing and able to provide written informed consent.

排除标准

  • Refusal to participate.
  • Infection or wound at the planned block site.
  • Decreased level of consciousness.
  • Known allergy to local anesthetics or opioids.
  • Coagulation disorder.
  • History of chronic pain.
  • Hyperalgesia.

研究组 & 干预措施

Control: General Anesthesia Only

No Intervention

Participants receive standard general anesthesia without rectus sheath block. Postoperative analgesia follows institutional protocol (e.g., PCA morphine and paracetamol).

Intervention: General Anesthesia + Bilateral Rectus Sheath Block

Experimental

Participants receive standard general anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (single-shot) using bupivacaine 0.25%, 20 mL per side, performed after induction of anesthesia.

干预措施: Ultrasound-guided rectus sheath block (Procedure)

结局指标

主要结局

Postoperative Pain Intensity (Numeric Rating Scale, NRS)

时间窗: 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery

Pain intensity measured using the Numeric Rating Scale (0-10; 0 = no pain, 10 = worst imaginable pain) by a blinded assessor.

次要结局

  • Time to First Opioid Request(Up to 24 hours after surgery)
  • Total Opioid Consumption(24 hours after surgery)
  • Change in Neutrophil-to-Lymphocyte Ratio (NLR)(Preoperative (1 day before surgery) and postoperative (in recovery room))
  • Postoperative Nausea and Vomiting (PONV(Up to 24 hours after surgery)

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prema Putra

Principal Investigator

Udayana University

研究点 (1)

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