PainPhase 2NCT02247648
Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy
A Phase 2 study testing tramadol in people with Pain and Vertigo, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2017
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged more than 18 year old
- arthroscopic shoulder surgery on interscalen block
- able to understand the protocol
- inform consent signed
Who cannot join
- chronic pain or chronic used of narcotics
- Use of IMAO
- Use of ISRS
- Pulmonary chronic disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de chirurgie spécialisée de Montréal
Montreal, Quebec, h3s 2w1
About this study
Official title: Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.
Read the detailed description
The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.
- Being tested
- tramadol, Placebo
- Keywords
- tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]
- Medical subject headings
- Pain, Vertigo, Nausea, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadolDrug
Also called tridural
Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
PlaceboDrug
Patients from control group received a "shame" tramadol pill on day one, two, and 3
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | treatment: tramadol group Receives: Drug: tramadol |
| control | Placebo comparator | control: placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of hydromorphone consumed
determination of the quantity of hydromorphone consumed at different laps
Measured: 3 days
Secondary outcomes (1)
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
evaluation of the pain at different laps
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Denis Roy, Doctor, Principal investigator, Head of the Anesthesia Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247648
- Sponsor's protocol ID
- unique Protocol ID
- Status last verified
- Feb 2018
- First submitted
- 15 Sep 2014
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT02247648
- Acronym / sponsor ID
- unique Protocol ID
- Keywords
- tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.
Detailed description
The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: tramadoltreatment: tramadol group |
| control | Placebo comparator | Drug: Placebocontrol: placebo group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged more than 18 year old
- arthroscopic shoulder surgery on interscalen block
- able to understand the protocol
- inform consent signed
Key exclusion criteria (4 listed)
- chronic pain or chronic used of narcotics
- Use of IMAO
- Use of ISRS
- Pulmonary chronic disease
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 |
|---|---|---|
| tramadolAlso: triduralPatients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3 | Drug | treatment |
| PlaceboPatients from control group received a "shame" tramadol pill on day one, two, and 3 | Drug | control |
Primary outcome
quantity of hydromorphone consumed
Time frame: 3 days
determination of the quantity of hydromorphone consumed at different laps
1 secondary outcome
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
Time frame: 3 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Jean-Denis Roy, Doctor principal investigator
Head of the Anesthesia Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tramadol in people with Pain and Vertigo, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Jul 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
quantity of hydromorphone consumed (time frame: 3 days). 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 24 Jul 2020.