Retrolaminar Analgesia for LuMbar Surgery

Официальное название

Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial

Обзор

This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.

Подробное описание

BACKGROUND: Lumbar spine surgery is associated with significant postoperative pain, which can delay recovery and increase complications. Regional anesthesia techniques, specifically retrolaminar blocks, may provide superior analgesia compared to systemic opioids alone.

STUDY DESIGN: This is a prospective, randomized, controlled trial conducted at Clínica Universidad de Los Andes, Chile. Patients will be allocated using variable block randomization (block sizes 4 and 6) in a 1:1 ratio.

INTERVENTIONS: All patients will receive standardized general anesthesia (Propofol, Remifentanil, Rocuronium) and multimodal analgesia including paracetamol, metamizol, ketorolac, morphine, and pregabalin. The intervention group will additionally receive bilateral ultrasound-guided retrolaminar blocks with ropivacaine 0.5% (20 ml per side) at the end of surgery.

OUTCOMES: Primary outcome is cumulative morphine consumption via patient-controlled analgesia (PCA) during the first 24 postoperative hours. Secondary outcomes include pain scores (VAS 0-10) at 0, 6, 12, 24, 48, and 72 hours; time to first rescue analgesia; duration of sensory block; incidence of nausea/vomiting; hospital length of stay; time to ambulation; sleep quality; patient satisfaction; adverse events; and development of chronic pain at 3 and 6 months.

SAMPLE SIZE: 50 patients (25 per group) provides 80% power to detect a clinically significant difference in opioid consumption.

Вмешательства

• Процедура Ultrasound-Guided Retrolaminar Block
  Patients will receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery. The block will be performed by an experienced anesthesiologist using real-time ultrasound guidance.
• Другое Standard Analgesia
  Patients receive standard multimodal analgesia without regional anesthesia block.

Первичные конечные точки

• Total postoperative opioid consumption [Срок оценки: First 24 hours after surgery]

Вторичные конечные точки (5)

• Pain Intensity [Срок оценки: Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours]
• Duration of Sensory Block [Срок оценки: From block performance up to 72 hours]
• Time to First Rescue Analgesia [Срок оценки: From end of surgery up to 24 hours]
• Incidence of PONV [Срок оценки: First 24 hours postoperatively]
• Length of hospital stay [Срок оценки: From admission to discharge, assessed up to 30 days]

Критерии участия

Критерии включения

• Adult patients aged 18-80 years
• Scheduled for elective lumbar spine surgery (with instrumentation)
• American Society of Anesthesiologists (ASA) physical status I-III
• Willing and able to provide written informed consent
• Able to use patient-controlled analgesia (PCA) device

Критерии исключения

• Refusal to participate in the study
• Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication
• Contraindication to regional anesthesia (infection at injection site, coagulopathy)
• Chronic opioid use (daily use for >3 months prior to surgery)
• Severe psychiatric disorder that precludes informed consent
• Emergency surgery
• Diabetes mellitus with preoperative glucose >180 mg/dl
• Pregnancy or breastfeeding
• Body mass index (BMI) >40 kg/m²
• Reoperation or revision of the same level of previous spinal surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Clínica Universidad de los Andes, Chile — Santiago

Публикации

• Zeballos JL, Voscopoulos C, Kapottos M, Janfaza D, Vlassakov K. Ultrasound-guided retrolaminar paravertebral block. Anaesthesia. 2013 Jun;68(6):649-51. doi: 10.1111/anae.12296. No abstract available. PMID 23662765
• Ardon AE, Prasad A, McClain RL, Melton MS, Nielsen KC, Greengrass R. Regional Anesthesia for Ambulatory Anesthesiologists. Anesthesiol Clin. 2019 Jun;37(2):265-287. doi: 10.1016/j.anclin.2019.01.005. Epub 2019 Mar 15. PMID 31047129
• Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available. PMID 21804697
• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. PMID 23392233

Идентификаторы

NCT: NCT07334288 · CUA2025-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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