Post Thoracic SurgeryPhase 4NCT03862404
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
A Phase 4 study testing Bupivacaine-epinephrine and Normal saline in people with Post Thoracic Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Thoracic Surgery
- What is being tested?
- Bupivacaine-epinephrine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 15 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia
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
- Being tested
- Bupivacaine-epinephrine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
See previous description
Normal salineDrug
See previous descreption
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients in this group receive Normal Saline injection in the inter pleural space Receives: Drug: Normal saline |
| Experimental group | Experimental | Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space Receives: Drug: Bupivacaine-epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS scores
ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours
Measured: from 0 hour to 24 hour
Secondary outcomes (3)
Forced Vital Capacity
Measured: from 0 hour to 48 hour
Total epidural infusion
Measured: from 0 hour to 48 hour
Co-analgesia consumption
Measured: from 0 hour to 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jul 2017
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- RCT with one active group and a control (placebo) group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JF Asenjo, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862404
- Sponsor's protocol ID
- 2017-3277
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia
- ClinicalTrials.gov ID
- NCT03862404
- Acronym / sponsor ID
- 2017-3277
- Conditions
- Post Thoracic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT with one active group and a control (placebo) group
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal salinePatients in this group receive Normal Saline injection in the inter pleural space |
| Experimental group | Experimental | Drug: Bupivacaine-epinephrinePatients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-epinephrineSee previous description | Drug | Experimental group |
| Normal salineSee previous descreption | Drug | Control group |
Primary outcome
Change in VAS scores
Time frame: from 0 hour to 24 hour
ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours
3 secondary outcomes
Forced Vital Capacity
Time frame: from 0 hour to 48 hour
Total epidural infusion
Time frame: from 0 hour to 48 hour
Co-analgesia consumption
Time frame: from 0 hour to 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-epinephrine and Normal saline in people with Post Thoracic Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS scores (time frame: from 0 hour to 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.