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Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Phase 4
Completed
Conditions
Pain, Postoperative
Interventions
Drug: Patient Controlled Analgesia (IV PCA)
Drug: Thoracic paravertebral block (TPVB)
Registration Number
NCT02302586
Lead Sponsor
Istanbul University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patient Controlled Analgesia (IV PCA)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
Thoracic Paravertebral Block (TPVB)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)
Primary Outcome Measures
NameTimeMethod
Postoperative chronic pain scores (VAS) at rest and during mobilizationUp to 6 months

Chronic pain follow-up

Secondary Outcome Measures
NameTimeMethod
Postoperative vital signs0-48 hours

Postoperative early period hemodynamic follow-up

Postoperative acute pain at rest and during coughing/mobilization0-48 hours

Postoperative acute pain score (VAS) follow-up

Postoperative nausea and vomiting (PONV) and antiemetic requirements0-48 hours

Postoperative acute PONV and antiemetic use follow-up

Postoperative morphine consumption0-48 hours

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

Time to first analgesic0-48 hours

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

Postoperative first oral intake, flatulence, defecation, mobilization times0-48 hours

Postoperative first oral intake, flatulence, defecation, mobilization times

Postoperative hospital discharge day and timeParticipants is being followed for the duration of hospital stay, an expected average of 1 week

Postoperative hospital discharge day and time

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

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

Trial Locations

Locations (1)

Istanbul University, Department of Anesthesiology

🇹🇷

Istanbul, Turkey

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