Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

Post Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862404
• Other study ID #: 2017-3277
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: March 2019
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Thoracic Surgery
• Shoulder Pain

Intervention

Drug:
• Bupivacaine-epinephrine
See previous description
• Normal saline
See previous descreption

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS scores	ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours	from 0 hour to 24 hour
Secondary	Forced Vital Capacity		from 0 hour to 48 hour
Secondary	Total epidural infusion		from 0 hour to 48 hour
Secondary	Co-analgesia consumption		from 0 hour to 48 hour