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Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03862404
Enrollment
42
Registered
2019-03-05
Start date
2017-07-01
Completion date
2019-02-15
Last updated
2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Thoracic Surgery

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.

Interventions

See previous description

DRUGNormal saline

See previous descreption

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Blinded drug preparation

Intervention model description

RCT with one active group and a control (placebo) group

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in VAS scoresfrom 0 hour to 24 hourISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours

Secondary

MeasureTime frame
Forced Vital Capacityfrom 0 hour to 48 hour
Total epidural infusionfrom 0 hour to 48 hour
Co-analgesia consumptionfrom 0 hour to 48 hour

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026