Retrolaminar block to reduce opioid use after lumbar fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, blinded, controlled trial compares a retrolaminar block with 0.25% bupivacaine and epinephrine to a sham block using saline in adults undergoing lumbar spine fusion. All participants receive standardized multimodal analgesia and are followed by the Acute Pain Unit for three days to track opioid use, pain scores, recovery quality, blood loss, and complications. The study aims to determine if the regional block reduces postoperative opioid requirements and improves early recovery without added risk. Enrollment occurs after institutional approvals and informed consent, with participants assigned 1:1 to intervention or sham. The trial is conducted at Hospital Clínico Pontificia Universidad Católica de Chile with sponsorship from Pontificia Universidad Catolica de Chile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínico Pontificia Universidad Católica de Chile
  Santiago, Santiago Metropolitan, Chile Recruiting

Study contacts

• Study coordinator: Juan Carlos De la Cuadra-Fontaine, MD
• Email: juancarl@ucchristus.cl
• Phone: 5695337297

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.