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Completed

NCT Number: NCT07126483

Thoracic Paravertebral Block vs Intrathecal Morphine in VATS

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.

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Key information

Conditions

Postoperative Acute Pain Intrathechal Morphine Neurologic Manifestations Pain Pain, Postoperative Paravertebral Peripheral Nerve Block Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Video-Assisted Thoracoscopic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Faculty of Medicine, Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: 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.

Other names: Intrathecal Morphine (ITM)

Primary outcomes

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

    Time frame: First 24 hours postoperatively

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

Secondary outcomes

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

    Time frame: First 12 hours postoperatively

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

  2. Time to First Analgesic Request

    Time frame: 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

  3. Numeric Rating Scale (NRS) Pain Scores at Rest

    Time frame: 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.

  4. Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing

    Time frame: 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.

  5. Sedation Score

    Time frame: 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

  6. Postoperative Nausea and Vomiting (PONV) Score

    Time frame: 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).

  7. Pruritus Score

    Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively

    Score of pruritus, assessed using a 4-point scale (0-3; 0 none, 1 mild/no treatment, 2 moderate/treatment, 3 severe/repeat treatment; treatment threshold ≥2)

  8. Rescue Analgesia Requirement

    Time frame: First 24 hours postoperatively

    Number of participants requiring additional analgesics beyond PCA during the first 24 hours postoperatively.

  9. Incidence of Postoperative Complications

    Time frame: First 30 postoperative days

    Number of participants experiencing any postoperative complication within 30 days

  10. Quality of Recovery questionnaire (QoR-15) score

    Time frame: Preoperative baseline (≤24 h before surgery), 24 h postoperatively, and at hospital discharge (anticipated within 3 days)

    Recovery quality wil be assessed with the validated Turkish QoR-15 (15 items; total 0-150, higher scores = better recovery).

  11. Intraoperative Remifentanil and Propofol Consumption

    Time frame: Intraoperative period (from induction to 240 min)

    Total intraoperative doses of remifentanil and propofol administered by the anesthesia team will be recorded.

  12. Intraoperative Hemodynamics (Heart Rate and Mean Arterial Pressure)

    Time frame: Intraoperative period (from induction to 240 min)

    Heart rate and mean arterial pressure will be recorded at standard clinical intervals.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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