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Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

This study has been completed.
Sponsor:
Collaborator:
Triemli Hospital
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00512395
First received: August 6, 2007
Last updated: NA
Last verified: March 2004
History: No changes posted
  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)
Drug: paracetamol, metmizole, morphine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

Resource links provided by NLM:

U.S. FDA Resources

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
 Drug: paracetamol, metmizole, morphine
standart paracetamole 500mg 6h; metamizole as needed, opioids as needed

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective laparoscopic colorectal resection

Exclusion Criteria:

  • emergency surgery
  • preoperatively planned stoma formation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00512395     History of Changes
Other Study ID Numbers: STZ 13/04
Study First Received: August 6, 2007
Last Updated: August 6, 2007
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Acetaminophen
Fentanyl
Morphine
Ropivacaine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Anesthetics, Local

ClinicalTrials.gov processed this record on June 18, 2013