Intrathecal Morphine for Recovery and Outcomes After VATS (IMPROVE-VATS)

Ataturk University

Status: Enrolling

Conditions: Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery

Treatments: Drug: Intrathecal Morphine; Drug: Dexmedetomidine; Procedure: Serratus Anterior Plane Block (SAPB) group

Study type: Interventional

Funder types: Other

Identifiers

NCT07231926

B.30.2.ATA.0.01.00/614

2025/2

Details and patient eligibility

About

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.

Full description

This is a single-center, prospective, randomized, double-blind clinical trial evaluating the efficacy of intrathecal morphine in combination with serratus anterior plane block (SAPB) and dexmedetomidine infusion for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS). Eligible patients are ASA I-II, aged 18-70 years, with BMI < 35 kg/m². Patients will be randomized into two groups using a computer-generated sequence. The intervention group will receive intrathecal morphine (200 µg) in addition to SAPB and dexmedetomidine, while the control group will receive SAPB and dexmedetomidine alone. The primary outcome is postoperative pain scores (VAS) within the first 24 hours. Secondary outcomes include opioid consumption, quality of recovery, and incidence of side effects.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective video-assisted thoracoscopic surgery (VATS) planned
• Age 18-70 years
• ASA physical status I-III
• Body mass index (BMI) <35 kg/m²

Exclusion criteria

• Coagulopathy
• Opioid dependence or intolerance
• Allergy to local anesthetics
• Contraindications to neuraxial blockade
• Chronic pain history
• Renal or hepatic failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

ITM + SAPB + Dex

Experimental group

Description:

Before induction, 200 µg intrathecal morphine via a 27G Sprotte spinal needle from L3-L4; intraoperative 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg/kg loading (15 min) followed by a 0.5 µg/kg/h infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine under ultrasound guidance at the end of surgery; basal tramadol PCA without infusion IV in the PACU (20 mg each bolus, maximum 200 mg/24 h); if necessary, 50 mg tramadol IV for VAS\>4.

Treatment:

Procedure: Serratus Anterior Plane Block (SAPB) group

Drug: Dexmedetomidine

Drug: Intrathecal Morphine

SAPB + Dex (No ITM)

Active Comparator group

Description:

Same protocol, but no intrathecal morphine. Intraoperatively, 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg/kg loading dose (15 min) followed by a 0.5 µg/kg/h infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine at the end of surgery; basal intravenous tramadol PCA (20 mg each bolus, maximum 200 mg/24 h) in the PACU; if necessary, 50 mg tramadol IV for VAS \>4.

Treatment:

Procedure: Serratus Anterior Plane Block (SAPB) group

Drug: Dexmedetomidine