Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Opioid consumption during the first 24 hours postoperative
研究概览
简要总结
This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia.
The participants will:
- Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision.
- Receive standardized multimodal analgesia.
- Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.
详细描述
After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent.
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, Care Provider, Investigator)
盲法说明
Due to the nature of the intervention, both patients and healthcare personnel involved in the intraoperative and postoperative care of the patients will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-75 years, scheduled for lumbar spine fusion surgery by a trauma team
- •American Society of Anesthesiologists (ASA) Classification I-III
- •Willing and able to provide written informed consent to participate in the study.
排除标准
- •History of chronic use of strong or weak opioids for more than 3 months.
- •Diagnosis of chronic pain and treatment by a pain management team.
- •ASA score greater than or equal to
- •Patients with prior lumbar spine surgery. Spinal instrumentation at the surgical site.
- •Estimated creatinine clearance less than 60 ml/min.
- •Coagulation disorder or abnormal coagulation tests.
- •Infection at the surgical site.
- •Weight less than 50 kg.
- •Altered mental status that prevents reliable evaluation.
- •Allergy to local anesthetics or analgesic drugs used in the study.
- •Patients with contraindications to peripheral nerve blocks.
- •Lumbar spine fixation due to oncologic disease or acute trauma.
- •Use of intraoperative neuromonitoring and TIVA.
研究组 & 干预措施
Retrolaminar block
Participants received retrolaminar block with 0.25% Bupivacaine (20 ml) plus epinephrine (5 mcg/ml), on both sides of the vertebral lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
干预措施: retrolaminar block (Procedure)
Sham block
Participants received a retrolaminar sham block with 0.9% saline solution (20 ml), on both sides of the vertebra lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
干预措施: Sham block (Procedure)
结局指标
主要结局
Opioid consumption during the first 24 hours postoperative
时间窗: Daily consumption during the first 24 hours
To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.
次要结局
- Daily Numeric Rating Score (NRS) during the first 3 postoperative days(Daily NRS during the first 3 postoperative days)
- Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.(Preoperative score and daily score during the first 3 postoperative days)
- bleeding and transfusions(Intraoperative and during the first 3 days)