Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPontificia Universidad Catolica de Chile
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
retrolaminar block
Procedure/SurgeryRetrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
Sham block
Procedure/SurgerySham block in the retrolaminar area with saline solution on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Retrolaminar blockExperimental treatment 1 intervention
Group B: Sham blockSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption during the first 24 hours postoperative
To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.
Time frame
Daily consumption during the first 24 hoursSecondary outcomes
1
Daily Numeric Rating Score (NRS) during the first 3 postoperative days
The NRS (Numeric Rating Scale) is commonly used to assess pain intensity. Its minimum score is 0, indicating no pain, and its maximum score is 10, indicating the worst pain imaginable. This scale is simple and allows patients to rate their pain using a number from 0 to 10. The objective is to assess the intensity of acute postoperative pain, expressed as NRS, during the first 3 postoperative days.
Time frame
Daily NRS during the first 3 postoperative days2
Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.
The QoR-15 is a validated instrument in the literature that assesses the quality of recovery in patients after surgery. It is a multidimensional measurement tool that allows healthcare professionals to gain an overview of the patient's well-being during the postoperative period. The questionnaire consists of 15 items, covering 5 dimensions: Physical Comfort, Physical Independence, Emotional Support, Psychological Well-being, and Satisfaction with Recovery. The minimum score on the scale is 0 points, and the maximum score is 150 points. This range is obtained by summing the scores of the different categories evaluated in the QoR-15 scale, where a higher score indicates a better quality of postoperative recovery.
Time frame
Preoperative score and daily score during the first 3 postoperative days3
bleeding and transfusions
Subjective assessment of total intraoperative bleeding (mild, moderate, severe), blood in collectors, number of compresses with blood, hematocrit variations at 24 hours after the procedure and need for transfusion in the perioperative period.
Time frame
Intraoperative and during the first 3 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov