Retrolaminar Analgesia for LuMbar Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidad de los Andes, Chile

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Retrolaminar Block

    Procedure/Surgery

    Patients will receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery. The block will be performed by an experienced anesthesiologist using real-time ultrasound guidance.

  • Standard Analgesia

    Other intervention

    Patients receive standard multimodal analgesia without regional anesthesia block.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Retrolaminar Block & Standard AnalgesiaExperimental treatment 1 intervention
Group B: Standard Analgesia OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative opioid consumption

Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours

Time frame
First 24 hours after surgery

Secondary outcomes

1

Pain Intensity

Pain intensity measured using Visual Analog Scale (VAS, 0-10 where 0=no pain and 10=worst imaginable pain) Time Frame: 0, 6, 12, 24, 48, and 72 hours postoperatively

Time frame
Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours
2

Duration of Sensory Block

Duration in hours from block performance until complete sensory recovery assessed by thermal and tactile testing

Time frame
From block performance up to 72 hours
3

Time to First Rescue Analgesia

Time in minutes from end of surgery until first request for rescue analgesia

Time frame
From end of surgery up to 24 hours
4

Incidence of PONV

Incidence of postoperative nausea and vomiting (PONV) requiring antiemetic rescue medication

Time frame
First 24 hours postoperatively

Other outcomes

1

Patient satisfaction

Patient satisfaction with pain management measured using 5-point Likert scale (1=very dissatisfied to 5=very satisfied)

Time frame
72 hours postoperatively
2

Chronic Pain Development

Incidence of chronic pain defined as VAS \> 3 at surgical site

Time frame
3 months and 6 months postoperatively

Sponsors and contacts

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