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CompletedNCT03862404Updated Mar 5, 2019

Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

A Phase 4 interventional study of Bupivacaine-epinephrine and Normal saline in Post Thoracic Surgery, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jul 2017, registered Feb 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Post Thoracic Surgery

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 415 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Placebo comparator
    Control group

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

    Drug: Normal saline

  • Experimental
    Experimental group

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

    Drug: Bupivacaine-epinephrine

Interventions

  • DrugBupivacaine-epinephrine

    See previous description

  • DrugNormal saline

    See previous descreption

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What researchers measure

Primary outcomes

  1. Change in VAS scores

    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 outcomes

  1. Forced Vital Capacity

    Time frame: from 0 hour to 48 hour

  2. Total epidural infusion

    Time frame: from 0 hour to 48 hour

  3. Co-analgesia consumption

    Time frame: from 0 hour to 48 hour

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Study locations

1 site
  • Montreal General Hospital
    Montreal, Quebec H3A 1A1, Canada
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03862404
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
JF Asenjo (Professor of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Mar 5, 2019
Start date
Jul 1, 2017
Primary completion
Feb 15, 2019
Completion
Feb 15, 2019
Last update
Mar 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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