Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy - Full Text View

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

MedlinePlus related topics:

Gallstones

ChemIDplus related topics:

Gabapentin Lidocaine Ketamine Ketamine hydrochloride Droperidol

U.S. FDA Resources

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

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	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

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

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

Study placed in the following topic categories:

Cholecystolithiasis

Gallbladder Diseases

Pathological Conditions, Anatomical

Excitatory Amino Acids

Cholelithiasis

Gallstones

Gabapentin

Lidocaine

Droperidol

Calculi

Digestive System Diseases

Dopamine

Biliary Tract Diseases

Ketamine

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Antiemetics

Antiparkinson Agents

Calcium Channel Blockers

Excitatory Amino Acid Agents

Membrane Transport Modulators

Sensory System Agents

Therapeutic Uses

Analgesics

Excitatory Amino Acid Antagonists

Tranquilizing Agents

Gastrointestinal Agents

Central Nervous System Depressants

Dopamine Antagonists

Cardiovascular Agents

Antimanic Agents

Antipsychotic Agents

Pharmacologic Actions

Adjuvants, Anesthesia

Autonomic Agents

Anti-Anxiety Agents

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on October 10, 2008

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