NCT07291388 Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
| NCT ID | NCT07291388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Acute Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-06-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07291388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07291388 currently recruiting?
Yes, NCT07291388 is actively recruiting participants. Contact the research team at juancarl@ucchristus.cl for enrollment information.
Where is the NCT07291388 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07291388 clinical trial?
NCT07291388 is sponsored by Pontificia Universidad Catolica de Chile. The trial plans to enroll 44 participants.