Ultrasound-Guided External Oblique Intercostal Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 24-hour cumulative opioid consumption
研究概览
简要总结
This randomized controlled study aims to compare the effects of the external oblique intercostal block (EOIB) and the erector spinae plane block (ESPB) on postoperative analgesia in adult patients undergoing elective laparoscopic cholecystectomy. Both EOIB and ESPB are ultrasound-guided regional anesthesia techniques currently used in clinical practice to improve postoperative pain control as part of multimodal analgesia strategies.
Laparoscopic cholecystectomy is a common minimally invasive surgical procedure; however, patients may still experience postoperative pain that can increase opioid consumption and delay recovery. Identifying the most effective regional anesthesia technique may improve postoperative analgesia and patient recovery.
In this study, eligible patients will be randomly assigned to receive either bilateral EOIB or bilateral ESPB in addition to standardized general anesthesia and postoperative patient-controlled analgesia. Postoperative pain scores, opioid consumption, quality of recovery, postoperative nausea and vomiting, and block-related complications will be evaluated during the first 24 hours after surgery. The study aims to provide comparative clinical evidence regarding the analgesic effectiveness of these two regional anesthesia techniques.
详细描述
This study is designed as a multicenter, prospective, randomized controlled trial aiming to evaluate and compare the postoperative analgesic outcomes of two ultrasound-guided regional anesthesia techniques, external oblique intercostal block (EOIB) and erector spinae plane block (ESPB), in adult patients undergoing elective laparoscopic cholecystectomy.EOIB and ESPB are ultrasound-guided regional anesthesia techniques that have been described for postoperative analgesia in upper abdominal surgery. In this study, the regional analgesic technique to be administered will be determined by randomization, while all other aspects of perioperative care will follow standard institutional practice. Except for the randomized allocation of the regional block technique, the research team will not alter routine anesthetic management.
The primary objective of the study is to compare cumulative intravenous morphine consumption during the first 24 hours after surgery between patients receiving EOIB and those receiving ESPB. Secondary objectives include assessment of postoperative pain scores at rest and during movement, quality of recovery, postoperative nausea and vomiting (PONV), intraoperative opioid consumption, rescue analgesic requirements, block-related complications, and opioid-related adverse effects.
Clinical Routine and Analgesic Protocol
All patients will be managed according to the standard multimodal analgesia protocol routinely used in the general surgery operating rooms of the participating institutions. Preoperatively, standard ASA monitoring will be applied, intravenous access will be established, and perioperative fluid management will be provided according to institutional practice. Mild sedation will be administered using intravenous midazolam at a dose of 0.02 mg/kg. Supplemental oxygen will be delivered via nasal cannula during block performance.
General anesthesia will be induced and maintained using routinely applied anesthetic agents. Intraoperative opioid administration will be titrated according to hemodynamic parameters to maintain mean arterial pressure and heart rate within acceptable limits, and total intraoperative opioid consumption will be recorded.
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
Block randomization lists will be generated using Microsoft Office 365 Excel (Microsoft, Redmond, WA, USA), and patients will be randomly assigned to one of the two study groups in a 1:1 ratio. According to the randomization result, group allocation will be placed in sealed opaque envelopes. Forty-five minutes before block performance, an independent nurse who is not involved in the study will deliver the envelope containing group assignment to the anesthesiologist performing the regional block.
Patients, surgeons, ward nurses, and all personnel involved in postoperative data collection and outcome assessment will remain blinded to group allocation. Investigators responsible for outcome evaluation and statistical analysis will also be blinded to the randomization results.
To ensure block quality and standardization, all regional blocks will be performed by a single experienced anesthesiologist who has performed each block technique at least 30 times. For masking purposes, this anesth
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Scheduled to undergo elective laparoscopic cholecystectomy
- •Classified as American Society of Anesthesiologists (ASA) physical status I-III
- •Ability to understand and operate a patient-controlled analgesia (PCA) device
- •Provision of written informed consent
排除标准
- •History of chronic opioid use for more than four weeks prior to surgery
- •Presence of pre-existing chronic pain conditions, such as migraine or fibromyalgia
- •History of alcohol or substance abuse
- •Known hypersensitivity or allergy to local anesthetics or opioids
- •Presence of severe organ dysfunction, including clinically significant hepatic or renal disease
- •Any contraindication to regional anesthesia
- •Severe psychiatric disorders impairing patient cooperation or the ability to reliably assess pain (e.g., psychosis, dementia)
- •Pregnancy or breastfeeding
- •Presence of hematological disorders
研究组 & 干预措施
Group EOIB
Patients allocated to the EOIB group will be transferred to the regional anesthesia area and monitored approximately 45 minutes before surgery. With the patient in the supine position, bilateral ultrasound-guided external oblique intercostal block (EOIB) will be performed. A total volume of 60 mL of 0.25% bupivacaine (30 mL per side) will be injected. General anesthesia will then be administered according to standard practice. In the postoperative period, additional analgesia will be provided using intravenous morphine patient-controlled analgesia (PCA).
干预措施: Ultrasound-Guided External Oblique Intercostal Block (Procedure)
Group ESPB
Patients allocated to the ESPB group will be transferred to the regional anesthesia area and monitored approximately 45 minutes before surgery. With the patient in the supine position, bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed. A total volume of 60 mL of 0.25% bupivacaine (30 mL per side) will be injected. General anesthesia will then be administered according to standard practice. In the postoperative period, additional analgesia will be provided using intravenous morphine patient-controlled analgesia (PCA).
干预措施: Ultrasound-Guided Erector Spinae Plane Block (Procedure)
结局指标
主要结局
24-hour cumulative opioid consumption
时间窗: postoperative day 1
Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).
次要结局
- 12-hour cumulative opioid consumption(postoperative 12th hour)
- Postoperative pain scores (NRS at rest)(postoperative day 1)
- Postoperative pain scores (NRS during activity)(postoperative day 1)
- Patient-reported quality of recovery (QoR-15 score)(postoperative day 1)
- Postoperative nausea and vomiting incidence (PONV)(Postoperative day 1)
- Time to first PCA analgesic demand(Postoperative day 1)
- Number of patients requiring rescue analgesia(Postoperative day 1)
- Block-related complications(Postoperative day 7)
- Opioid-related adverse effects(Postoperative day 7)
研究者
Elif Sarikaya Ozel
Principal Investigator- M.D. Karabuk Training and Research Hospital, Department of Anesthesiology
Karabuk University