Back to resultsIntrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
Primary Purpose
Post Thoracic Surgery
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine-epinephrine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Post Thoracic Surgery
Eligibility Criteria
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
Sites / Locations
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Patients in this group receive Normal Saline injection in the inter pleural space
Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space
Outcomes
Primary Outcome Measures
Change in VAS scores
ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours
Secondary Outcome Measures
Forced Vital Capacity
Total epidural infusion
Co-analgesia consumption
Full Information
NCT ID
NCT03862404
First Posted
February 19, 2019
Last Updated
March 4, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT03862404
Brief Title
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
Official Title
Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thoracic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
RCT with one active group and a control (placebo) group
Masking
ParticipantOutcomes Assessor
Masking Description
Blinded drug preparation
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients in this group receive Normal Saline injection in the inter pleural space
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-epinephrine
Intervention Description
See previous description
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
See previous descreption
Primary Outcome Measure Information:
Title
Change in VAS scores
Description
ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours
Time Frame
from 0 hour to 24 hour
Secondary Outcome Measure Information:
Title
Forced Vital Capacity
Time Frame
from 0 hour to 48 hour
Title
Total epidural infusion
Time Frame
from 0 hour to 48 hour
Title
Co-analgesia consumption
Time Frame
from 0 hour to 48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
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