Thoracic Paravertebral Block vs Intrathecal Morphine in VATS

NCT07126483 | Completed

• 1 other identifier: ITMTPVB2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Thoracic Paravertebral Block; Intrathecal Morphine;; Video-Assisted Thoracoscopic Surgery; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  First 24 hours postoperatively

Secondary Outcomes (12)

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

  First 12 hours postoperatively

• Time to First Analgesic Request

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

• Numeric Rating Scale (NRS) Pain Scores at Rest

  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

• Sedation Score

  0, 3, 6, 12, 18, and 24 hours postoperatively

Study Arms (2)

Thoracic Paravertebral Block (TPVB)

EXPERIMENTAL

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.

Procedure: Thoracic paravertebral block

Intrathecal Morphine (ITM)

EXPERIMENTAL

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.

Drug: Morphine

Interventions

Thoracic paravertebral block 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.

Also known as: TPVB

Thoracic Paravertebral Block (TPVB)

Morphine 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.

Also known as: Intrathecal Morphine (ITM)

Intrathecal Morphine (ITM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective video-assisted thoracoscopic surgery (VATS) for wedge resection, segmentectomy, or lobectomy
• Ability to understand the study protocol and provide written informed consent

You may not qualify if:

• Refusal to participate
• Pregnancy
• Morbid obesity (body mass index \> 30)
• Known allergy to opioids, local anesthetics, or NSAIDs
• History of neuropsychiatric disorder, cognitive impairment, or inability to communicate with investigators
• History of substance abuse
• Current anticoagulant use or known bleeding disorder
• Presence of systemic infection
• Significant cardiovascular, hepatic, renal, or endocrine disease
• History of chronic pain syndromes or chronic pain treatment
• Emergency surgery or previous ipsilateral VATS or thoracotomy
• Preoperative chronic opioid therapy within 3 months (≥15 mg/day for ≥30 days)
• Severe intraoperative or postoperative bleeding, hemodynamic instability
• Requirement for prolonged postoperative ventilation (\> 18 hours)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 18, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)