Paravertebral Block or External Oblique Intercostal Block? A Comparative Analysis of Pain and Opioid Consumption After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- 24-hour postoperative tramadol consumption
研究概览
简要总结
This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.
详细描述
This single center, prospective, randomised controlled clinical trial is designed to evaluate analgesic efficacy and opioid sparing effect of ultrasound guided paravertebral block (PVB) and external oblique intercostal (EOI) block versus systemic opioid based analgesia in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Pain after laparoscopic cholecystectomy is often moderate to severe during the first 24 hours , and has somatic and visceral components . Regional approaches that target thoracoabdominal dermatomes and visceral afferents may provide superior analgesia, allow for earlier mobilisation, and reduce opioid-related adverse effects compared with intravenous opioid regimens alone. PVB provides unilateral segmental blockade at thoracic paravertebral level, while the EOI block deposits local anaesthetic in the fascial plane between the external oblique and intercostal muscles, with spread to relevant thoracoabdominal nerves.
In a parallel-group design, participants will be randomly allocated to bilateral thoracic PVB, bilateral EOI block or no truncal block with standard systemic analgesia. All regional blocks will be performed under ultrasound guidance after induction of general anaesthesia. Standardised volumes and concentrations of long-acting local anaesthetic will be used according to institutional practice. The control group will receive patient-controlled intravenous opioid analgesia as part of a multimodal approach.
Standardisation of intraoperative monitoring and technique of general anaesthesia according to departmental protocols will be done for perioperative anaesthetic management. Postoperative pain intensity will be assessed by an 11-point Numerical Rating Scale at specified time points during the first 24 hours. Rescue analgesia will be administered according to a predefined algorithm. The trial's purpose is to compare postoperative opioid use between groups and to investigate differences in pain trajectories and opioid-related adverse events in routine clinical conditions.
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
- Single (Outcomes Assessor)
盲法说明
The investigator assessing postoperative pain scores will be blinded to the intervention group allocation. Patients and anesthesia providers will not be blinded.
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 for elective laparoscopic cholecystectomy under general anesthesia
- •ASA physical status I-III
- •Able to understand the study procedure and provide informed consent
排除标准
- •Patient refusal or inability to provide informed consent
- •Allergy or contraindication to local anesthetics, tramadol, or study medications
- •Coagulopathy or current anticoagulant therapy
- •Local infection at the planned block injection site
- •Severe hepatic or renal impairment
- •Chronic opioid use or opioid dependence
- •Neurological or psychiatric disorders affecting pain perception or communication
- •Pregnancy or breastfeeding
- •Body mass index (BMI) > 35 kg/m²
- •Conversion to open cholecystectomy during surgery
研究组 & 干预措施
Paravertebral Block Group
Participants in this arm will receive bilateral paravertebral block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be administered to provide postoperative analgesia following laparoscopic cholecystectomy. Patients will also receive standard intravenous paracetamol postoperatively.
干预措施: Paravertebral Block (PVB) (Procedure)
External Oblique Intercostal Block Group
Participants in this arm will receive bilateral external oblique intercostal (EOI) block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be injected into the fascial plane between the external oblique and intercostal muscles. Standard intravenous paracetamol will be administered postoperatively.
干预措施: External Oblique Intercostal Block (EOI Block) (Procedure)
Control Group - IV PCA Tramadol
Participants in this arm will receive intravenous patient-controlled analgesia (PCA) with tramadol for postoperative pain management. The PCA pump will be set to a maximum dose of 400 mg tramadol in 24 hours. Standard intravenous paracetamol (1 g every 8 hours) will also be administered. No regional anesthesia block will be performed in this group.
干预措施: Tramadol IV Patient-Controlled Analgesia (PCA) (Drug)
结局指标
主要结局
24-hour postoperative tramadol consumption
时间窗: Within the first 24 hours after surgery.
Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.
次要结局
- Postoperative pain scores at rest(1, 6, 12, and 24 hours postoperatively)
- Postoperative pain scores at rest(1, 6, 12, and 24 hours postoperatively)
- Incidence of postoperative nausea and vomiting(Within 24 hours postoperatively)
- Incidence of block-related complications(Intraoperative and first 24 hours after block)
- Patient satisfaction with analgesia(24 hours postoperatively)
研究者
Nurefsan Sadikoglu
Attending Specialist
Cukurova University