Colon CancerNCT01062919
Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
A study testing Epidural analgesia and Wound catheter in people with Colon Cancer and Inflammatory Bowel Diseases, run by Franco Carli at 2 sites in Canada.
Trial summary
This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- What is being tested?
- Epidural analgesia and Wound catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2009to Oct 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective open colon surgery
Who cannot join
- ASA physical status 4
- history of:
- hepatic failure (liver enzymes abnormally elevated)
- renal failure (creatinine over 150 mmol/L)
- cardiac failure
- organ transplant
Show all 15Show fewer
- diabetes
- morbid obesity (BMI > 40 kg/m-2)
- chronic use of opioids
- allergy to local anaesthetics
- History of seizure
- contraindications to the insertion of epidural
- INR > 1.3, PTT > 44 second, platelets < 150.000 per microliter,
- previous spinal surgery limiting the insertion)
- inability to comprehend pain assessment
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3H1A4
Montreal General Hospital
Montreal, Quebec, H3H1V9
About this study
Official title: Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.
Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).
Read more
Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.
Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.
Read the detailed description
This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Being tested
- Epidural analgesia, Wound catheter
- 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.
Epidural analgesiaProcedure or surgery
Also called Thoracic epidural analgesia
patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.
Wound catheterProcedure or surgery
Also called Wound catheter continuous infusion
patients in the epidural analgesia group will receive 0.2%ropivacaine through the wound catheter, normal saline in the epidural catheter and PCA with morphine.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia group | Experimental | patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine. Receives: Procedure: Epidural analgesia |
| Wound Group | Experimental | patients in the epidural analgesia group will receive ropivacaine 0.2% through the wound catheter, normal saline in the epidural catheter and PCA with morphine. Receives: Procedure: Wound catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative functional recovery
Measured: at 24, 48, 72 hours, 4 and 8 weeks after the surgery
Secondary outcomes (5)
postoperative pain
Measured: at 24, 48, 72 hours after the surgery
opioid consumption
Measured: at 24, 48, 72 hours after the surgery
opioid side effects
Measured: at 24, 48, 72 hours after the surgery
return of bowel function
Measured: at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.
length of hospital stay
Measured: at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Low recruitment rate - \>70% of colorectal procedures are done laparoscopically
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franco Carli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, Professor, Principal investigator, McGill University Healt Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062919
- Sponsor's protocol ID
- GEN-08-070
- Status last verified
- Aug 2015
- First submitted
- 22 Sep 2009
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
- ClinicalTrials.gov ID
- NCT01062919
- Acronym / sponsor ID
- GEN-08-070
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate - \>70% of colorectal procedures are done laparoscopically
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Franco CarliUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Feb 2010 (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 double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.
Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).
Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.
Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.
Detailed description
This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia group | Experimental | Procedure: Epidural analgesiapatients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine. |
| Wound Group | Experimental | Procedure: Wound catheterpatients in the epidural analgesia group will receive ropivacaine 0.2% through the wound catheter, normal saline in the epidural catheter and PCA with morphine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective open colon surgery
Key exclusion criteria (15 listed)
- ASA physical status 4
- history of:
- History of seizure
- contraindications to the insertion of epidural
- INR > 1.3, PTT > 44 second, platelets < 150.000 per microliter,
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 |
|---|---|---|
| Epidural analgesiaAlso: Thoracic epidural analgesiapatients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine. | Procedure or surgery | Epidural analgesia group |
| Wound catheterAlso: Wound catheter continuous infusionpatients in the epidural analgesia group will receive 0.2%ropivacaine through the wound catheter, normal saline in the epidural catheter and PCA with morphine. | Procedure or surgery | Wound Group |
Primary outcome
Postoperative functional recovery
Time frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery
5 secondary outcomes
postoperative pain
Time frame: at 24, 48, 72 hours after the surgery
opioid consumption
Time frame: at 24, 48, 72 hours after the surgery
opioid side effects
Time frame: at 24, 48, 72 hours after the surgery
return of bowel function
Time frame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.
length of hospital stay
Time frame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.
Results and safety
The study was stopped early (reason given: Low recruitment rate - \>70% of colorectal procedures are done laparoscopically). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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 principal investigator
McGill University Healt Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia and Wound catheter in people with Colon Cancer and Inflammatory Bowel Diseases, run by Franco Carli at 2 sites 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 15 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate - \>70% of colorectal procedures are done laparoscopically). 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?
Postoperative functional recovery (time frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery). 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 4 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.