Thoracic Paravertebral Block vs Intrathecal Morphine in VATS
- Conditions
- Postoperative Acute PainVideo-Assisted Thoracoscopic SurgeryIntrathechal MorphineParavertebral Peripheral Nerve Block
- Interventions
- Procedure: Thoracic paravertebral block
- Registration Number
- NCT07126483
- Lead Sponsor
- Ondokuz Mayıs University
- Brief 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 (PCA) 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thoracic Paravertebral Block (TPVB) Thoracic paravertebral block Patients in this group will receive a single-injection ultrasound-guided thoracic paravertebral block before induction of standardized general anesthesia. The block will be performed using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000). Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. Intrathecal Morphine (ITM) Morphine Patients in this group will receive a single dose of intrathecal 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. Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs.
- Primary Outcome Measures
Name Time Method Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery First 24 hours postoperatively Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours.
- Secondary Outcome Measures
Name Time Method Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery First 12 hours postoperatively Total amount of IV-MME administered during the first 12 postoperative hours.
Time to First Analgesic Request From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively Duration from the time the patient is extubated and able to communicate after surgery to the first patient-controlled analgesia (PCA) demand for analgesia
Numeric Rating Scale (NRS) Pain Scores at Rest 0, 3, 6, 12, 18, and 24 hours postoperatively Pain intensity at rest measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively.
Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing 0, 3, 6, 12, 18, and 24 hours postoperatively Pain intensity during coughing or deep breathing measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively.
Sedation Score 0, 3, 6, 12, 18, and 24 hours postoperatively Sedation Score assessed using the Ramsay Sedation Scale (1-6) at 0, 3, 6, 12, 18, and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV) Score 0, 3, 6, 12, 18, and 24 hours postoperatively Score of PONV, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = single episode of vomiting, 3 = multiple episodes of vomiting).
Pruritus Score 0, 3, 6, 12, 18, and 24 hours postoperatively Score of pruritus, assessed using a 4-point scale (0 = none, 1 = itching sensation without scratching, 2 = scratching, 3 = severe itching requiring treatment).
Rescue Analgesia Requirement First 24 hours postoperatively Number of participants requiring additional analgesics beyond PCA during the first 24 hours postoperatively.
Incidence of Postoperative Complications First 30 postoperative days Number of participants experiencing any postoperative complication within 30 days