Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia

Official title

Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia

Overview

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.

Detailed description

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.

Interventions

• Procedure retrolaminar block
  Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
• Procedure Sham block
  Sham block in the retrolaminar area with saline solution on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.

Primary outcome measures

• Opioid consumption during the first 24 hours postoperative [Time frame: Daily consumption during the first 24 hours]

Secondary outcome measures (3)

• Daily Numeric Rating Score (NRS) during the first 3 postoperative days [Time frame: 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. [Time frame: Preoperative score and daily score during the first 3 postoperative days]
• bleeding and transfusions [Time frame: Intraoperative and during the first 3 days]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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 4.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Chile · 1 center

• Hospital Clínico Pontificia Universidad Católica de Chile — Santiago

Publications

• 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
• Machado GC, Ferreira PH, Harris IA, Pinheiro MB, Koes BW, van Tulder M, Rzewuska M, Maher CG, Ferreira ML. Effectiveness of surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PLoS One. 2015 Mar 30;10(3):e0122800. doi: 10.1371/journal.pone.0122800. eCollection 2015. PMID 25822730
• Pepper CG, Mikhaeil JS, Khan JS. Perioperative Regional Anesthesia on Persistent Opioid Use and Chronic Pain after Noncardiac Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Anesth Analg. 2024 Oct 1;139(4):711-722. doi: 10.1213/ANE.0000000000006947. Epub 2024 Sep 4. PMID 39231035
• Kaye AD, Kandregula S, Kosty J, Sin A, Guthikonda B, Ghali GE, Craig MK, Pham AD, Reed DS, Gennuso SA, Reynolds RM, Ehrhardt KP, Cornett EM, Urman RD. Chronic pain and substance abuse disorders: Preoperative assessment and optimization strategies. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):255-267. doi: 10.1016/j.bpa.2020.04.014. Epub 2020 May 7. PMID 32711832
• Garg B, Ahuja K, Sharan AD. Regional Anesthesia for Spine Surgery. J Am Acad Orthop Surg. 2022 Sep 1;30(17):809-819. doi: 10.5435/JAAOS-D-22-00101. Epub 2022 May 25. PMID 35617645
• Voscopoulos C, Palaniappan D, Zeballos J, Ko H, Janfaza D, Vlassakov K. The ultrasound-guided retrolaminar block. Can J Anaesth. 2013 Sep;60(9):888-95. doi: 10.1007/s12630-013-9983-x. PMID 23797663
• Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block. Biomed Res Int. 2019 Mar 28;2019:2578396. doi: 10.1155/2019/2578396. eCollection 2019. PMID 31032339
• Karmakar MK, Sivakumar RK, Sheah K, Pangthipampai P, Lonnqvist PA. Quest for the Elusive Mechanism of Action for the Thoracic Paraspinal Nerve Block Techniques. Are We Ignoring the Anatomy of the "Retro Superior Costotransverse Ligament Space?". Anesth Analg. 2023 Aug 1;137(2):458-465. doi: 10.1213/ANE.0000000000006462. Epub 2023 Jul 14. No abstract available. PMID 37450909

Identifiers

NCT: NCT07291388 · 241022008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗