Colon CancerPhase 1/2NCT01477190
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
A Phase 1/2 study testing Spinal analgesia in people with Colon Cancer and Inflammatory Bowel Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- What is being tested?
- Spinal analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo laparoscopic colonic resection
Who cannot join
- patients who have trouble to understand, read or communicate either in French or in English
- dementia
- patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
- patients suffering from severe cardiac or respiratory disease (status ASA IV)
- patients suffering from metastatic carcinoma
- patients who have a history of chemoradiation within the six months preceding surgery
- morbid obesity
- contraindication to spinal analgesia
Trial locations and contacts
1 site in 1 country.
About this study
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.
Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
Read the detailed description
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Being tested
- Spinal analgesia, Patient Control Analgesia (PCA) Morphine
- Medical subject headings
- Colonic Neoplasms, Inflammatory Bowel Diseases, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal analgesiaDrug
Also called Spinal block, intrathecal block
isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years.
Patient Control Analgesia (PCA) MorphineDrug
Also called Patient Control Analgesia Morphine.
PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Spinal group | Experimental | Isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years. Receives: Drug: Spinal analgesia |
| PCA group | Active comparator | PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes. Receives: Drug: Patient Control Analgesia (PCA) Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: daily during hospitalization up to 3 days after the operation
Secondary outcomes (2)
opioid consumption
Measured: daily during hospitalization up to 3 days after the operation
opioid side effects
Measured: daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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, Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, Professor, Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477190
- Sponsor's protocol ID
- GEN-06-023(2)
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
- ClinicalTrials.gov ID
- NCT01477190
- Acronym / sponsor ID
- GEN-06-023(2)
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Nov 2011 (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.
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.
Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
Detailed description
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal group | Experimental | Drug: Spinal analgesiaIsobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years. |
| PCA group | Active comparator | Drug: Patient Control Analgesia (PCA) MorphinePCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo laparoscopic colonic resection
Key exclusion criteria (8 listed)
- patients who have trouble to understand, read or communicate either in French or in English
- dementia
- patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
- patients suffering from severe cardiac or respiratory disease (status ASA IV)
- patients suffering from metastatic carcinoma
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 |
|---|---|---|
| Spinal analgesiaAlso: Spinal block, intrathecal blockisobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years. | Drug | Spinal group |
| Patient Control Analgesia (PCA) MorphineAlso: Patient Control Analgesia Morphine.PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes. | Drug | PCA group |
Primary outcome
postoperative pain
Time frame: daily during hospitalization up to 3 days after the operation
2 secondary outcomes
opioid consumption
Time frame: daily during hospitalization up to 3 days after the operation
opioid side effects
Time frame: daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days
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 28 Nov 2011.
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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.
Franco Carli, Professor study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spinal analgesia in people with Colon Cancer and Inflammatory Bowel Diseases, 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 8 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 28 Nov 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
postoperative pain (time frame: daily during hospitalization up to 3 days after the operation). 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 28 Nov 2011.