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Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512395
First Posted: August 7, 2007
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Triemli Hospital
Information provided by:
University Hospital, Basel, Switzerland
  Purpose
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.

Condition Intervention Phase
Pain Drug: epidural analgesia (Duracain/Fentanyl/Naropin) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • pain (VAS), cramps (VAS) and quantity of analgesics [ Time Frame: 8 days ]

Secondary Outcome Measures:
  • duration of postoperative ileus morbidity [ Time Frame: 6 months ]

Enrollment: 75
Study Start Date: November 2004
Study Completion Date: January 2007
Arms Assigned Interventions
Active Comparator: 1
epidural analgesia
Drug: epidural analgesia (Duracain/Fentanyl/Naropin)
naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h
No Intervention: 2
traditional analgesia with opioids

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective laparoscopic colorectal resection

Exclusion Criteria:

  • emergency surgery
  • preoperatively planned stoma formation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512395


Locations
Switzerland
Triemli Hospital
Zurich, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Triemli Hospital
Investigators
Principal Investigator: Urs Zingg, MD University Hospital, Basel, Switzerland
  More Information

ClinicalTrials.gov Identifier: NCT00512395     History of Changes
Other Study ID Numbers: STZ 13/04
First Submitted: August 6, 2007
First Posted: August 7, 2007
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Basel, Switzerland:
laparoscopic colorectal surgery
epidural analgesia
pain score
postoperative ileus

Additional relevant MeSH terms:
Fentanyl
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local