Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-02-15

Brief Summary

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While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.

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Detailed Description

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Conditions

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Post Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

RCT with one active group and a control (placebo) group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Blinded drug preparation

Study Groups

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Control group

Patients in this group receive Normal Saline injection in the inter pleural space

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

See previous descreption

Experimental group

Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space

Group Type EXPERIMENTAL

Bupivacaine-epinephrine

Intervention Type DRUG

See previous description

Interventions

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Bupivacaine-epinephrine

See previous description

Intervention Type DRUG

Normal saline

See previous descreption

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy

Exclusion Criteria

* ASA \>3, morbid obesity BMI\>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes