BridgeMD
Tests treatment safety and results for Acute Pain
Official title Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
ClinicalTrials.gov ID: NCT07291388
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Santiago Metropolitan, Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Santiago Metropolitan, Chile. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.