- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512395
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications.
Primary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland
- Triemli Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- elective laparoscopic colorectal resection
Exclusion Criteria:
- emergency surgery
- preoperatively planned stoma formation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
epidural analgesia
|
naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h
|
No Intervention: 2
traditional analgesia with opioids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain (VAS), cramps (VAS) and quantity of analgesics
Time Frame: 8 days
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration of postoperative ileus morbidity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Urs Zingg, MD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STZ 13/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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