Thoracic Surgery, Video-assistedPhase 4NCT02152514
RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo
A Phase 4 study testing Intrathecal Morphine/Sufentanil and PCA in people with Thoracic Surgery, Video-assisted and Postoperative Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia
- What is being tested?
- Intrathecal Morphine/Sufentanil and PCA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VATS
- ASA 1,2 or 3
- Minimum weight of 50 kg
- Patient able to consent
Who cannot join
- Patient refusal
- Patient unable to understand PCA
- Contraindication to rachianalgesia
- Zona
- Pregnancy
- Over 30 mg of morphine during the last 24 hours
Show all 11Show fewer
- Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain
- Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic
- Intubation over 1 hour after surgery (unability to use PCA)
- High risk of conversion to thoracotomy
- Unable to perform rachianalgesia due to technical difficulties
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.
Read the detailed description
This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.
- Conditions
- Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia, Sufentanil, Morphine
- Being tested
- Intrathecal Morphine/Sufentanil, PCA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Morphine/SufentanilDrug
PCADevice
Also called Patient Controlled Analgesia
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine/Sufentanil and PCA | Active comparator | Patients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period. Receives: Drug: Intrathecal Morphine/Sufentanil; Device: PCA |
| PCA alone | Placebo comparator | Patients will NOT receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will only have a PCA for analgesia in the post-operative period. Receives: Device: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydromorphone consommation
The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.
Measured: 24hr
Secondary outcomes (4)
Pain
A VAS will be used.
Measured: Every 4h x 24hr
Adverse effects of narcotics
Including :
- Saturation [Saturation (%) and the need for oxygen (l/min) will be assess to evaluate the incidence of desaturation and hypoventilation in both arms]
- Sedation [Sedation will be evaluate with the Riker Sedation Agitation Scale]
- Respiratory rate [To evaluate the incidence of hypoventilation (<8/min) and to compare the average between both arms]
Measured: Every 4h x 24hr
Adverse reactions associate with rachianesthesia
Including :
- Backache
- Headache
- Legs strength
Measured: 24hr
Adverse reactions of narcotics
Including :
- Nausea
- Pruritis
- Urinary retention
Measured: 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Due to technical details recruitment was unreasonably slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery, Video-assistedStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanick Sansoucy, Université de Sherbrooke
- Investigators
- Yanick Sansoucy, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152514
- Sponsor's protocol ID
- Epimorph for VATS
- Status last verified
- Jan 2016
- First submitted
- 23 May 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
- ClinicalTrials.gov ID
- NCT02152514
- Acronym / sponsor ID
- Epimorph for VATS
- Conditions
- Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia, Sufentanil, Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to technical details recruitment was unreasonably slow
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Jun 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 purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.
Detailed description
This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine/Sufentanil and PCA | Active comparator | Drug: Intrathecal Morphine/Sufentanil, Device: PCAPatients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period. |
| PCA alone | Placebo comparator | Device: PCAPatients will NOT receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will only have a PCA for analgesia in the post-operative period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- VATS
- ASA 1,2 or 3
- Minimum weight of 50 kg
- Patient able to consent
Key exclusion criteria (11 listed)
- Patient refusal
- Patient unable to understand PCA
- Contraindication to rachianalgesia
- Zona
- Pregnancy
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 |
|---|---|---|
| Intrathecal Morphine/Sufentanil | Drug | Intrathecal Morphine/Sufentanil and PCA |
| PCAAlso: Patient Controlled Analgesia | Device | Intrathecal Morphine/Sufentanil and PCA, PCA alone |
Primary outcome
Hydromorphone consommation
Time frame: 24hr
The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.
4 secondary outcomes
Pain
Time frame: Every 4h x 24hr
Adverse effects of narcotics
Time frame: Every 4h x 24hr
Adverse reactions associate with rachianesthesia
Time frame: 24hr
Adverse reactions of narcotics
Time frame: 24hr
Results and safety
The study was stopped early (reason given: Due to technical details recruitment was unreasonably slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
Yanick Sansoucy principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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 Intrathecal Morphine/Sufentanil and PCA in people with Thoracic Surgery, Video-assisted and Postoperative Pain, run by Université de Sherbrooke 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 11 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 20 Jan 2016. 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 was stopped early (reason given: Due to technical details recruitment was unreasonably slow). 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?
Hydromorphone consommation (time frame: 24hr). 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 20 Jan 2016.