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CompletedNCT07126483

Thoracic Paravertebral Block vs Intrathecal Morphine in VATS

A Randomized Controlled Non-Inferiority Trial Comparing Thoracic Paravertebral Block and Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Ondokuz Mayıs University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the spinal fluid. We want to see if ITM works as well as TPVB in reducing the need for pain medicine during the first 24 hours after surgery. People in the study will get either TPVB or ITM before going to sleep for surgery, use a patient-controlled pain pump after surgery, and have their pain scores, medicine use, recovery, and possible side effects checked for up to 30 days after surgery.

Detailed description

This study will compare two different pain control techniques for people having video-assisted thoracoscopic surgery (VATS), a minimally invasive chest operation. The first technique, called thoracic paravertebral block (TPVB), involves injecting numbing medicine near the spine to block pain from the surgical area. The second technique, intrathecal morphine (ITM), involves giving a small dose of morphine into the spinal fluid to provide pain relief after surgery. The main goal is to find out if ITM works as well as TPVB in reducing the need for additional pain medicine during the first 24 hours after surgery. This is a randomized controlled trial, meaning participants will be randomly assigned to one of the two groups. Everyone will receive general anesthesia for their surgery and will use a patient-controlled analgesia pump afterwards, along with regular pain medicines such as paracetamol and tenoxicam. Pain scores, the amount of pain medicine used, and recovery quality will be measured at regular times in the first 24 hours after surgery. We will also monitor side effects such as nausea, vomiting, itching, or breathing problems. All patients will be followed for 30 days after surgery to check for any complications.

Conditions

Interventions

TypeNameDescription
PROCEDUREThoracic paravertebral blockUltrasound-guided single-injection thoracic paravertebral block using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000) before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs.
DRUGMorphineSingle intrathecal injection of morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs.

Timeline

Start date
2025-08-18
Primary completion
2026-01-01
Completion
2026-01-01
First posted
2025-08-17
Last updated
2026-01-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07126483. Inclusion in this directory is not an endorsement.

Thoracic Paravertebral Block vs Intrathecal Morphine in VATS (NCT07126483) · Clinical Trials Directory