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Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209885
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Hvidovre University Hospital
  Purpose
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Condition Intervention Phase
Cholecystolithiasis Drug: Gabapentin Drug: S-ketamine Drug: Lidocaine Drug: Droperidol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 1. postoperative abilities over time in PACU
  • 2. discharge time from PACU according to fixed criteria
  • 3. consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measures:
  • 1. Degree of nursing requirements in the PACU
  • 2. General tolerability of the regimens

Estimated Enrollment: 60
Study Start Date: October 2005
Detailed Description:

Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:

  • A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
  • B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.

Primary endpoints:

  • postoperative abilities over time
  • discharge time from PACU according to fixed criteria
  • consumption of analgesics and antiemetics in the PACU

Secondary endpoints:

  • degree of nursing requirements at the PACU
  • General tolerability of the regimes
  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 cholecystectomy
  • Age above 18 years
  • Written informed consent
  • ASA class I-III

Exclusion Criteria:

  • Planned abdominal cholecystectomy
  • Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
  • Allergy to part of the treatment regimens
  • Previous reactions to opioids (nausea, cognition)
  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): NCT00209885


Contacts
Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk

Locations
Denmark
Dept of Anaesthesia, Hvidovre Hospital Not yet recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Kenneth Jensen, M.D.    +45 36 32 62 90    kenneth.jensen@hh.hosp.dk   
Principal Investigator: Kenneth Jensen, M.D.         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Kenneth Jensen, M.D. Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Study Chair: Claus Lund, dr.med.sci Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00209885     History of Changes
Other Study ID Numbers: OMA-LC01
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Lidocaine
Ketamine
Gabapentin
Droperidol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents