Thoracic Paravertebral Block vs Intrathecal Morphine in VATS

NCT ID: NCT07126483

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-01-01

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 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

Postoperative Acute Pain; Video-Assisted Thoracoscopic Surgery; Intrathechal Morphine; Paravertebral Peripheral Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Thoracic Paravertebral Block (TPVB)

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.

Group Type: EXPERIMENTAL

Thoracic paravertebral block

Intervention Type: PROCEDURE

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.

Intrathecal Morphine (ITM)

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.

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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.

Interventions

Thoracic paravertebral block

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.

Intervention Type: PROCEDURE

Morphine

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.

Intervention Type: DRUG

Other Intervention Names

TPVB; Intrathecal Morphine (ITM)

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Cengiz KAYA

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology, Faculty of Medicine, Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ITMTPVB2025

Identifier Type: -

Identifier Source: org_study_id