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NCT Number: NCT02302586

Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

About this study

Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function.

Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA

Exclusion criteria

Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use

Treatment and study plan

Thoracic paravertebral block (TPVB)

Drug

Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique

Other names: Bupivacaine

Patient Controlled Analgesia (IV PCA)

Drug

IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg

Other names: Morphine

Primary outcomes

  1. Postoperative chronic pain scores (VAS) at rest and during mobilization

    Time frame: Up to 6 months

    Chronic pain follow-up

Secondary outcomes

  1. Postoperative vital signs

    Time frame: 0-48 hours

    Postoperative early period hemodynamic follow-up

  2. Postoperative acute pain at rest and during coughing/mobilization

    Time frame: 0-48 hours

    Postoperative acute pain score (VAS) follow-up

  3. Postoperative nausea and vomiting (PONV) and antiemetic requirements

    Time frame: 0-48 hours

    Postoperative acute PONV and antiemetic use follow-up

  4. Postoperative morphine consumption

    Time frame: 0-48 hours

    Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic

  5. Time to first analgesic

    Time frame: 0-48 hours

    Postoperative first analgesic IV PCA morphine demand time for Group 1 and first rescue analgesic IV morphine time for Group 2

  6. Postoperative first oral intake, flatulence, defecation, mobilization times

    Time frame: 0-48 hours

    Postoperative first oral intake, flatulence, defecation, mobilization times

  7. Postoperative hospital discharge day and time

    Time frame: Participants is being followed for the duration of hospital stay, an expected average of 1 week

    Postoperative hospital discharge day and time

  8. Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up

    Time frame: Up to 6 months

    Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up with phone call

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial

Acronym: VATS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2014
Registry last updated
Aug 3, 2017

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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