Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Patient Controlled Analgesia (IV PCA)

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Thoracic paravertebral block (TPVB)

Intervention Type 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

Interventions

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Thoracic paravertebral block (TPVB)

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

Intervention Type DRUG

Patient Controlled Analgesia (IV PCA)

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

Intervention Type DRUG

Other Intervention Names

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Bupivacaine Morphine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No