Optimal Multimodal Analgesia in Abdominal Hysterectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2005 by Hvidovre University Hospital.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00209872

First Posted: September 21, 2005

Last Update Posted: November 7, 2007

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.

Information provided by:

Hvidovre University Hospital

Purpose

The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Condition	Intervention	Phase
Planned Abdominal Hysterectomy	Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measures:

Degree of nursing requirements at the PACU
General tolerability of the regimes
Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively


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, for patients admitted for planned abdominal hysterectomy with or without BSO:

A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Planned abdominal hysterectomy with or without BSO
Age above 18 years
Written informed consent
American Society of Anesthesiologists (ASA) class I-III

Exclusion Criteria:

Planned vaginal or laparoscopic hysterectomy
Hysterectomy as part of other surgery
Allergy to part of the treatment regimen
Previous reactions to opioids (nausea, cognition)
Previous inability to place correct epidural catheter
Severe state anxiety according to the OCAP or STAI
ASA class IV
Dependency on alcohol, opioids or central stimulants
Chronic pain condition
Hemorrhagic diathesis
Participation in another study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209872

Contacts


Contact: Kenneth Jensen, M.D.	+45 36 32 62 90	kenneth.jensen@hh.hosp.dk

Locations


Denmark
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

Additional Information:

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


ClinicalTrials.gov Identifier:	NCT00209872 History of Changes
Other Study ID Numbers:	OMA-AH01 eudraCT # 2005-003595-38
First Submitted:	September 14, 2005
First Posted:	September 21, 2005
Last Update Posted:	November 7, 2007
Last Verified:	September 2005

Additional relevant MeSH terms:


Lidocaine Ketamine Gabapentin Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Analgesics	Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Antimanic Agents

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