Analgesic Efficacy of Low-Volume Versus Standard-Volume 0.25% Bupivacaine for Ultrasound-Guided External Oblique and Rectus Abdominis Plane Block in Laparoscopic Cholecystectomy, A Randomized Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Dynamic numerical rating scale (NRS) score at 4 hours postoperatively.
研究概览
简要总结
The original EXORA block used high local anesthetic volume (50 mL total), raising concerns about local anesthetic systemic toxicity (LAST). In such a bilaterally administered regional technique, evaluating the efficacy of a reduced-volume approach is warranted to maximize patient safety.
详细描述
Study Design & Population This is a prospective, randomized, double-blinded trial enrolling patients scheduled for elective laparoscopic cholecystectomy. Following informed consent, patients will be randomly allocated into two equal groups to evaluate different volumes used in a bilateral, ultrasound-guided External Oblique and Rectus Abdominis (EXORA) block.
Interventions Prior to the induction of general anesthesia, patients will receive a bilateral EXORA block using 0.25% bupivacaine.
Group E15: Will receive 15 mL of the local anesthetic on each side. Group E25: Will receive 25 mL of the local anesthetic on each side. Blinding & Allocation Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The block will be performed by a designated regional anesthesiologist who will not be involved in subsequent patient care. The patient, the surgical team, the intraoperative anesthesiologist, and the postoperative data collectors will remain strictly blinded to the group allocation and the volume injected.
Anesthesia & Perioperative Management Sensory block distribution will be assessed prior to surgery. All patients will receive a standardized general anesthesia protocol for induction and maintenance. Intraoperative hemodynamics will be managed according to standard institutional protocols.
Postoperative Analgesia & Monitoring Upon transfer to the Post-Anesthesia Care Unit (PACU) and throughout the first 24 hours, all patients will receive scheduled, standardized multimodal analgesia (intravenous paracetamol and ketorolac). Postoperative pain will be assessed using the 11-point Numerical Rating Scale (NRS) at rest and during movement at prespecified time points. If the dynamic NRS score is ≥ 4, intravenous morphine (2 mg) will be administered . Patients will be continuously monitored for adverse events, including postoperative nausea and vomiting (PONV), hemodynamic instability, and local anesthetic systemic toxicity (LAST), which will be managed with predefined rescue medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
排除标准
- •• Patient refusal to participate.
- •Obese patients with a body mass index of more than 35 kg/m
- •Known cognitive impairment or use of psychiatric drugs
- •Known allergy to local anesthetics
- •Infection at the needle insertion site.
- •Coagulopathy, or bleeding disorders.
- •Pregnancy
- •History of chronic pain or chronic opioid use.
- •Previous major upper abdominal surgery (which alters the fascial planes and anatomy).
- •Criteria for Withdrawal from Study Analysis (Drop-outs):
- •Conversion to open cholecystectomy during surgery.
- •Failed EXORA block
研究组 & 干预措施
EXORA 25
25 mL of bupivacaine 0.25% administered bilaterally
干预措施: EXORA block 25 (Procedure)
EXORA 15
15 mL of bupivacaine 0.25% administered bilaterally
干预措施: EXORA block 15 (Procedure)
结局指标
主要结局
Dynamic numerical rating scale (NRS) score at 4 hours postoperatively.
时间窗: 4 hours after surgery
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough
次要结局
- Static Numerical Rating scale NRS scores(up to 24 hours post operatively)
- Dynamic numerical rating scale NRS scores(up to 24 hours post operatively)
- Cumulative Static Pain Burden(Up to 24h postoperatively)
- Cumulative Dynamic Pain Burden(Up to 24h postoperatively)
- Intraoperative Fentanyl consumption Total fentanyl in micrograms(From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours])
- Total cumulative consumption of intravenous morphine over the first 24 hours.(At 24 hours postoperatively)
- Time to first rescue analgesia(Upon recovery from General anesthesia up to 24 hours postoperatively])
- Sensory block distribution level (pin-prick test)(At 30 minuets from the block)
- Quality of recovery score (QoR-15) at 24 hours.(At 24 hours postoperatively)
- Incidence of adverse events: bradycardia, hypotension, PONV, and LAST.(From induction of anesthesia up to 24 hours postoperatively)
- Heart rate(Upon arrival to Operating Room until 24 hours postoperative)
- Mean arterial pressure(Upon arrival to Operating Room until 24 hours postoperative)
- sedation scores(up to 24 hours)
- Ramsay Sedation Scale (RSS)(up to 24 hours)
研究者
Mohamed Ahmed Hamed
Professor of Anesthesiology
Fayoum University Hospital