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Clinical Trials/NCT02302586
NCT02302586
Completed
Phase 4

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

Istanbul University1 site in 1 country60 target enrollmentSeptember 2014

Overview

Phase
Phase 4
Intervention
Patient Controlled Analgesia (IV PCA)
Conditions
Pain, Postoperative
Sponsor
Istanbul University
Enrollment
60
Locations
1
Primary Endpoint
Postoperative chronic pain scores (VAS) at rest and during mobilization
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nuzhet Mert Senturk, MD, Prof

MD, Prof. Dr

Istanbul University

Eligibility Criteria

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

Arms & Interventions

Patient Controlled Analgesia (IV PCA)

Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg

Intervention: Patient Controlled Analgesia (IV PCA)

Thoracic Paravertebral Block (TPVB)

Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique)

Intervention: Thoracic paravertebral block (TPVB)

Outcomes

Primary Outcomes

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

Time Frame: Up to 6 months

Chronic pain follow-up

Secondary Outcomes

  • Postoperative vital signs(0-48 hours)
  • Postoperative acute pain at rest and during coughing/mobilization(0-48 hours)
  • Postoperative nausea and vomiting (PONV) and antiemetic requirements(0-48 hours)
  • Postoperative morphine consumption(0-48 hours)
  • Time to first analgesic(0-48 hours)
  • Postoperative first oral intake, flatulence, defecation, mobilization times(0-48 hours)
  • Postoperative hospital discharge day and time(Participants is being followed for the duration of hospital stay, an expected average of 1 week)
  • Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up(Up to 6 months)

Study Sites (1)

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