Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 14, 2005

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

1. Degree of nursing requirements in the PACU
2. General tolerability of the regimens

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Official Title ^ICMJE

Brief Summary

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cholecystolithiasis

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kenneth Jensen, M.D.

+45 36 32 62 90

kenneth.jensen@hh.hosp.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00209885

Responsible Party

Study ID Numbers ^ICMJE

OMA-LC01

Study Sponsor ^ICMJE

Hvidovre University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Hvidovre University Hospital

Verification Date

September 2005

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