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Intrathecal Morphine for Recovery and Outcomes After VATS

ConditionPostoperative Pain Management in Video-Assisted Thoracoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAtaturk University

About this trial

This study will compare two different methods of pain management in patients undergoing video-assisted thoracoscopic surgery (VATS). One group will receive a combination of spinal morphine, nerve block, and dexmedetomidine, while the other group will receive a nerve block and dexmedetomidine without spinal morphine. All patients will receive standard pain medications after surgery. The purpose is to see if adding spinal morphine improves pain control and recovery after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective video-assisted thoracoscopic surgery (VATS) planned

Age 18-70 years

ASA physical status I-III

Body mass index (BMI) <35 kg/m²

Disqualifiers

Coagulopathy

Opioid dependence or intolerance

Allergy to local anesthetics

Contraindications to neuraxial blockade

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine

    Drug

    200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.

  • Serratus Anterior Plane Block (SAPB) group

    Procedure/Surgery

    Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.

  • Dexmedetomidine

    Drug

    Loading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: ITM + SAPB + DexExperimental treatment 3 interventions
Group B: SAPB + Dex (No ITM)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Quality of Recovery-15 (QoR-15) Score

The Quality of Recovery-15 (QoR-15) questionnaire is a validated 15-item instrument that assesses patient-centered postoperative recovery, including pain, physical comfort, emotional state, and overall wellbeing. The total score ranges from 0 to 150, with higher scores indicating better recovery.

Time frame
Measured 24 hours after surgery

Secondary outcomes

1

Time to First Rescue Opioid

Duration (in hours) from the end of surgery to the first administration of rescue opioid (intravenous tramadol) when the Visual Analog Scale (VAS) pain score exceeds 4.

Time frame
Within 24 hours postoperatively
2

Postoperative Pain Scores (VAS)

Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Both active (movement) and passive (rest) VAS scores will be recorded at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours after surgery. Higher scores indicate more severe pain.

Time frame
From postoperative hour 2 to hour 24.
3

Total Opioid Consumption

Cumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.

Time frame
24 hours postoperatively
4

Intraoperative Complications

Occurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ataturk University

Lead sponsor

Source ClinicalTrials.gov
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