Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia

NCT07291388 | Not Yet Recruiting DMC

• 1 other identifier: 241022008
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Pain; Anesthesia; Lumbar Spine Disease

Keywords

acute pain; retrolaminar block; regional anesthesia; lumbar arthrodesis

Outcome Measures

Primary Outcomes (1)

• Opioid consumption during the first 24 hours postoperative

  To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.

  Daily consumption during the first 24 hours

Secondary Outcomes (3)

• 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

Study Arms (2)

Retrolaminar block

EXPERIMENTAL

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.

Procedure: retrolaminar block

Sham block

SHAM COMPARATOR

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.

Procedure: Sham block

Interventions

retrolaminar block PROCEDURE

Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.

Retrolaminar block

Sham block PROCEDURE

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.

Sham block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Peker K, Aydin G, Gencay I, Saracoglu AG, Sahin AT, Ogden M, Peker SA. The effect of preemptive retrolaminar block on lumbar spinal decompression surgery. Eur Spine J. 2024 Nov;33(11):4253-4261. doi: 10.1007/s00586-024-08219-4. Epub 2024 Jun 17.

  PMID: 38886235 BACKGROUND

• Schnabel A, Yahiaoui-Doktor M, Meissner W, Zahn PK, Pogatzki-Zahn EM. Predicting poor postoperative acute pain outcome in adults: an international, multicentre database analysis of risk factors in 50,005 patients. Pain Rep. 2020 Jul 27;5(4):e831. doi: 10.1097/PR9.0000000000000831. eCollection 2020 Jul-Aug.

  PMID: 32766467 BACKGROUND

• Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17.

  PMID: 36414472 BACKGROUND

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 BACKGROUND

• Kaciroglu A, Ekinci M, Gurbuz H, Ulusoy E, Ekici MA, Dogan O, Golboyu BE, Alver S, Ciftci B. Surgical vs ultrasound-guided lumbar erector spinae plane block for pain management following lumbar spinal fusion surgery. Eur Spine J. 2024 Jul;33(7):2630-2636. doi: 10.1007/s00586-024-08347-x. Epub 2024 Jun 4.

  PMID: 38834814 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Spinal Diseases; Ankylosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Central Study Contacts

Juan Carlos De la Cuadra-Fontaine, MD

CONTACT

5695337297; juancarl@ucchristus.cl

Victor Contreras, MSN

CONTACT

56223543414; vecontre@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, two-group clinical trial

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share