Optimal Multimodal Analgesia in Abdominal Hysterectomy - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00209872

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 IV

MedlinePlus related topics: Anesthesia Hysterectomy Nausea and Vomiting

Drug Information available for: Gabapentin Lidocaine Ketamine Ketamine hydrochloride

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:

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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209872

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

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

Study ID Numbers:	OMA-AH01, eudraCT # 2005-003595-38
Study First Received:	September 14, 2005
Last Updated:	November 6, 2007
ClinicalTrials.gov Identifier:	NCT00209872
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Excitatory Amino Acids
Calcium, Dietary
Gabapentin
Ketamine
Lidocaine

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009