NCT07334288 Retrolaminar Analgesia for LuMbar Surgery
| NCT ID | NCT07334288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de los Andes, Chile |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-06-01 |
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 50 participants in total. It began in 2026-03-01 with a primary completion date of 2027-06-01.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Nicolas J Valls, M.D, Ph.D
STUDY DIRECTOR
Anesthesiologyst, Clinica Universidad de los Andes
Frequently Asked Questions
Who can join the NCT07334288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07334288 currently recruiting?
Yes, NCT07334288 is actively recruiting participants. Contact the research team at rcoloma@clinicauandes.cl for enrollment information.
Where is the NCT07334288 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07334288 clinical trial?
NCT07334288 is sponsored by Universidad de los Andes, Chile. The principal investigator is Nicolas J Valls, M.D, Ph.D at Anesthesiologyst, Clinica Universidad de los Andes. The trial plans to enroll 50 participants.