Thoracic Paravertebral Block vs Intrathecal Morphine in VATS

Ondokuz Mayıs University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Interventions

Thoracic paravertebral blockPROCEDURE

Ultrasound-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.

MorphineDRUG

Single 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Age between 18 and 75 years 2. American Society of Anesthesiologists (ASA) physical status I-III 3. Scheduled for elective video-assisted thoracoscopic surgery (VATS) for wedge resection, segmentectomy, or lobectomy 4. Ability to understand the study protocol and provide written informed consent Exclusion Criteria 1. Refusal to participate 2. Pregnancy 3. Morbid obesity (body mass index \> 30) 4. Known allergy to opioids, local anesthetics, or NSAIDs 5. History of neuropsychiatric disorder, cognitive impairment, or inability to communicate with investigators 6. History of substance abuse 7. Current anticoagulant use or known bleeding disorder 8. Presence of systemic infection 9. Significant cardiovascular, hepatic, renal, or endocrine disease 10. History of chronic pain syndromes or chronic pain treatment 11. Emergency surgery or previous ipsilateral VATS or thoracotomy 12. Preoperative chronic opioid therapy within 3 months (≥15 mg/day for ≥30 days) 13. Severe intraoperative or postoperative bleeding, hemodynamic instability 14. Requirement for prolonged postoperative ventilation (\> 18 hours)

Outcomes

Primary Outcomes

Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery

Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours.

Time frame: First 24 hours postoperatively

Secondary Outcomes

Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery

Total amount of IV-MME administered during the first 12 postoperative hours.

Time frame: First 12 hours postoperatively

Time to First Analgesic Request

Duration from the time the patient is extubated and able to communicate after surgery to the first patient-controlled analgesia (PCA) demand for analgesia

Time frame: From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively

Numeric Rating Scale (NRS) Pain Scores at Rest

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.