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Optimal Multimodal Analgesia in Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT00209872
Recruitment Status : Unknown
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2005
Last Update Posted : November 7, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Planned Abdominal Hysterectomy Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Postoperative abilities over time
  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 at the PACU
  2. General tolerability of the regimes
  3. Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively

Eligibility Criteria

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:
ClinicalTrials.gov Identifier: NCT00209872     History of Changes
Other Study ID Numbers: OMA-AH01
eudraCT # 2005-003595-38
First Posted: September 21, 2005    Key Record Dates
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