Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

NCT ID: NCT00512395

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

epidural analgesia

Group Type ACTIVE_COMPARATOR

epidural analgesia (Duracain/Fentanyl/Naropin)

Intervention Type DRUG

naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h

2

traditional analgesia with opioids

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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epidural analgesia (Duracain/Fentanyl/Naropin)

naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elective laparoscopic colorectal resection

Exclusion Criteria

* emergency surgery
* preoperatively planned stoma formation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triemli Hospital

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Principal Investigators

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Urs Zingg, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Triemli Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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STZ 13/04

Identifier Type: -

Identifier Source: org_study_id

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