Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

NCT03862404 | Completed Phase 4

• 1 other identifier: 2017-3277
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Normal saline

Experimental group

EXPERIMENTAL

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

Drug: Bupivacaine-epinephrine

Interventions

Bupivacaine-epinephrine DRUG

See previous description

Experimental group

Normal saline DRUG

See previous descreption

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded drug preparation
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Model Details: RCT with one active group and a control (placebo) group

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 5, 2019
• Study Start: July 1, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

CA (1)