Acute Pain, Anesthesia, Lumbar Spine Disease
Conditions
Keywords
acute pain, retrolaminar block, regional anesthesia, lumbar arthrodesis
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.
Interventions
PROCEDUREretrolaminar block
Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
PROCEDURESham block
Sham 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.
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Randomized, blinded, two-group clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption during the first 24 hours postoperative | Daily consumption during the first 24 hours | To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Numeric Rating Score (NRS) during the first 3 postoperative days | Daily 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. |
| 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 | 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. |
| bleeding and transfusions | Intraoperative and during the first 3 days | 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. |
Contacts
Primary ContactJuan Carlos De la Cuadra-Fontaine, MD
Backup ContactVictor Contreras, MSN
Outcome results
None listed