Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy - Full Text View

Sponsor:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00209885

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Gallstones

Drug Information available for: Gabapentin Lidocaine Droperidol Ketamine

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209885

Contacts

Contact: Kenneth Jensen, M.D.

+45 36 32 62 90

kenneth.jensen@hh.hosp.dk

Locations

Denmark, Hvidovre
Dept of Anaesthesia, Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650

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:

URL looking into anaesthesia and surgery for cholecystectomy This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	OMA-LC01
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00209885 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Anesthetics
Antiemetics
Excitatory Amino Acid Agents
Calculi

Membrane Transport Modulators
Sensory System Agents
Biliary Tract Diseases
Therapeutic Uses
Analgesics
Anti-Arrhythmia Agents
Excitatory Amino Acid Antagonists
Cholelithiasis
Tranquilizing Agents
Gallstones
Lidocaine
Droperidol
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists

ClinicalTrials.gov processed this record on November 27, 2009