ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

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.
ClinicalTrials.gov Identifier: NCT00209885
Recruitment Status : Unknown
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Sponsor:
Information provided by:
Hvidovre University Hospital

September 14, 2005
September 21, 2005
September 21, 2005
October 2005
Not Provided
  • 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
Same as current
No Changes Posted
  • 1. Degree of nursing requirements in the PACU
  • 2. General tolerability of the regimens
Same as current
Not Provided
Not Provided
 
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
Not Provided
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

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Cholecystolithiasis
  • Drug: Gabapentin
  • Drug: S-ketamine
  • Drug: Lidocaine
  • Drug: Droperidol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
Not Provided
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00209885
OMA-LC01
Not Provided
Not Provided
Not Provided
Not Provided
Hvidovre University Hospital
Not Provided
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
Hvidovre University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP