跳至主要内容
临床试验/CTRI/2024/11/076170
CTRI/2024/11/076170
招募中
4 期

Comparison of Retrolaminar block and Erector spinae plane block for post-operative analgesia in patients undergoing lumbar spine decompression surgery A prospective randomized controlled trial.

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年11月20日最近更新:

概览

阶段
4 期
状态
招募中
发起方
AIIMS JODHPUR
入组人数
84
试验地点
1
主要终点
The primary outcome of our study will be to compare postoperative pain score using Numeric Rating Scale (NRS) in GROUP RLB & GROUP ESPB.

概览

简要总结

Surgical procedures on the spine often result in significant postoperative pain, with inadequate pain control affecting recovery and increasing chronic pain risk. Traditionally, opioids have been used for pain management, but ERAS protocols encourage a multimodal approach to reduce opioid reliance. Regional anesthesia techniques, particularly peripheral nerve blocks like the erector spinae plane (ESP) block and retrolaminar (RL) block, are gaining attention for their effectiveness and fewer side effects compared to neuraxial methods. The ESP block targets spinal nerve rami and sympathetic nerves, while the RL block focuses on dorsal rami. Both techniques have shown promise in reducing pain and opioid consumption, but more comparative studies are needed to determine the best option for postoperative analgesia in spine surgery.

In the present study, patients will be randomly assigned to receive either a Retrolaminar block (RL) or an Erector Spinae Plane block (ES). Patients will undergo routine evaluations and fasting protocols. In the operating room, ASA standard monitors will be attached, induction of anesthesia will be performed, and the allocated block will be performed using ultrasound guidance after placing the patients in the surgical position (prone).

Group ‘RLB’ (Retrolaminar Block )- All patients will receive ultrasound (US) guided Retrolaminar block with 15 mL of 0.375% Ropivacaine on either side.

Group ‘ESPB’(Erector Spinae Plane Block)-All patients will receive ultrasound guided Erector Spinae Plane Block with 15 ml of 0.375% Ropivacaine on either side.

Block performance time, number of attempts, and complications will be recorded. Anesthesia maintenance will include isoflurane and rocuronium, with intraoperative analgesia provided by fentanyl and paracetamol. Postoperative pain will be assessed using a numerical rating scale (NRS), and rescue analgesia will be administered as needed. Side effects and patient satisfaction will also be documented throughout the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult Patients of either sex, aged between 18 to 65 years, belonging to ASA physical status 1 or 2, and scheduled for elective lumbar spine decompression surgery.

排除标准

  • Pregnant or lactating female.
  • History of bleeding diathesis or receiving anticoagulant treatment.
  • Skin infection at the site of the block area.
  • Patients with baseline cognitive deficits sufficient to make objective pain assessment unreliable.
  • Opioid-dependent or chronic analgesic abuse.
  • Patients with known allergy to amide local anaesthetic or opioid.

结局指标

主要结局

The primary outcome of our study will be to compare postoperative pain score using Numeric Rating Scale (NRS) in GROUP RLB & GROUP ESPB.

时间窗: During the first 24 hours after surgery

次要结局

  • 1. To compare the time to first rescue analgesic requirement.(2. To compare total analgesic consumed during the first 24 hrs after surgery.)

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sadik Mohammed

Department of Anaesthesiology and Critical Care, AIIMS Jodhpur

研究点 (1)

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