Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was  Not yet recruiting
Information provided by:
Hvidovre University Hospital Identifier:
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

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
Drug: Gabapentin
Drug: S-ketamine
Drug: Lidocaine
Drug: Droperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00209885

Contact: Kenneth Jensen, M.D. +45 36 32 62 90

Dept of Anaesthesia, Hvidovre Hospital Not yet recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Kenneth Jensen, M.D.    +45 36 32 62 90   
Principal Investigator: Kenneth Jensen, M.D.         
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Kenneth Jensen, M.D. Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Study Chair: Claus Lund, Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
  More Information

Additional Information:
No publications provided Identifier: NCT00209885     History of Changes
Other Study ID Numbers: OMA-LC01
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on November 25, 2014