Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

Phase 4

Completed

• Conditions: Post Thoracic Surgery
• Interventions: Drug: Bupivacaine-epinephrine; Drug: Normal saline

• Registration Number: NCT03862404
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Study First Submitted: 2019-02-19
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Bupivacaine-epinephrine	Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space
Control group	Normal saline	Patients in this group receive Normal Saline injection in the inter pleural space

Primary Outcome Measures

Name	Time	Method
Change in VAS scores	from 0 hour to 24 hour	ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity	from 0 hour to 48 hour
Total epidural infusion	from 0 hour to 48 hour
Co-analgesia consumption	from 0 hour to 48 hour

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada