Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Istanbul University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Istanbul University, Department of Anesthesiology

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Chronic pain follow-up

Time frame: Up to 6 months

Secondary Outcomes

Postoperative vital signs

Postoperative early period hemodynamic follow-up

Time frame: 0-48 hours

Postoperative acute pain at rest and during coughing/mobilization

Postoperative acute pain score (VAS) follow-up

Time frame: 0-48 hours

Postoperative nausea and vomiting (PONV) and antiemetic requirements

Postoperative acute PONV and antiemetic use follow-up

Time frame: 0-48 hours

Postoperative morphine consumption

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

Time frame: 0-48 hours

Time to first analgesic

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

Time frame: 0-48 hours

Postoperative first oral intake, flatulence, defecation, mobilization times

Time frame: 0-48 hours

Postoperative hospital discharge day and time

Data from ClinicalTrials.gov

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