Completed

NCT Number: NCT03862404

Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Thoracic Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-epinephrine

Drug

See previous description

normal saline

Drug

See previous descreption

Primary outcomes

Change in VAS scores

Time frame: from 0 hour to 24 hour

ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours

Secondary outcomes

Forced Vital Capacity

Time frame: from 0 hour to 48 hour
Total epidural infusion

Time frame: from 0 hour to 48 hour
Co-analgesia consumption

Time frame: from 0 hour to 48 hour

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Mar 5, 2019
Registry last updated: Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.