Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 44
- Primary Endpoint
- Opioid consumption during the first 24 hours postoperative
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Opioid consumption during the first 24 hours postoperative
Time Frame: Daily consumption during the first 24 hours
To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.
Secondary Outcomes
- 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)