Colonic DiseasesNCT01105442
Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice
An observational study of Colonic Diseases and Post-operative Pain, run by Martini Hospital Groningen at 1 site in Netherlands.
Trial summary
The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Diseases, Post-operative Pain, Local Anesthesia
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Jul 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Martini Hospital Groningen
Who may be able to join
- Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment
Who cannot join
- Patients who are admitted to an other ward
- Patients with a spinal catheter
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Martini Hospital ward 4b
Groningen, Provincie Groningen, 9700 RM
About this study
The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand. The expectation is that the use of levobupivacaine leads to less side effects.
- Conditions
- Colonic Diseases, Post-operative Pain, Local Anesthesia
- Keywords
- Post-operative pain treatment, Fast-track colonic surgery patients, Surgery
- Medical subject headings
- Colonic Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Patients who received bupivacaine + sufentanil | |
| Levobupivacaine | Patients who received levobupivacaine and morphine on demand |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Marinus van Hulst, Dr., Study chair, Martini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105442
- Sponsor's protocol ID
- METC2010-18
- Status last verified
- Mar 2010
- First submitted
- 15 Apr 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice
- ClinicalTrials.gov ID
- NCT01105442
- Acronym / sponsor ID
- METC2010-18
- Conditions
- Colonic Diseases, Post-operative Pain, Local Anesthesia
- Keywords
- Post-operative pain treatment, Fast-track colonic surgery patients, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Apr 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.
The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand. The expectation is that the use of levobupivacaine leads to less side effects.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | – | –Patients who received bupivacaine + sufentanil |
| Levobupivacaine | – | –Patients who received levobupivacaine and morphine on demand |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Martini Hospital Groningen
Key inclusion criteria (1 listed)
- Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment
Key exclusion criteria (2 listed)
- Patients who are admitted to an other ward
- Patients with a spinal catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Jul 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.
Marinus van Hulst, Dr. study chair
Martini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diseases and Post-operative Pain, run by Martini Hospital Groningen at 1 site in Netherlands.
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 2 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 21 Jul 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 Netherlands. 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 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.
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 21 Jul 2011.