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Clinical Trials/NCT00512395
NCT00512395CompletedPhase 4

Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

University Hospital, Basel, Switzerland1 site in 1 country75 target enrollmentStarted: November 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
pain (VAS), cramps (VAS) and quantity of analgesics

Study Overview

Brief Summary

Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • elective laparoscopic colorectal resection

Exclusion Criteria

  • emergency surgery
  • preoperatively planned stoma formation

Arms & Interventions

1

Active Comparator

epidural analgesia

Intervention: epidural analgesia (Duracain/Fentanyl/Naropin) (Drug)

Outcomes

Primary Outcomes

pain (VAS), cramps (VAS) and quantity of analgesics

Time Frame: 8 days

Secondary Outcomes

  • duration of postoperative ileus morbidity(6 months)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other

Study Sites (1)

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