- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209872
Optimal Multimodal Analgesia in Abdominal Hysterectomy
November 6, 2007 updated by: Hvidovre University Hospital
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kenneth Jensen, M.D.
- Phone Number: +45 36 32 62 90
- Email: kenneth.jensen@hh.hosp.dk
Study Locations
-
-
Hvidovre
-
Copenhagen, Hvidovre, Denmark, 2650
- Dept. of Anaesthesia, Hvidovre Hospital
-
Contact:
- Kenneth Jensen, M.D.
- Phone Number: +45 36 32 62 90
- Email: kenneth.jensen@hh.hosp.dk
-
Principal Investigator:
- Kenneth Jensen, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Postoperative abilities over time
|
Discharge time from PACU according to fixed criteria
|
Consumption of analgesics and antiemetics in the PACU
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
November 7, 2007
Last Update Submitted That Met QC Criteria
November 6, 2007
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Antidepressive Agents
- Anti-Anxiety Agents
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Antimanic Agents
- Ketamine
- Lidocaine
- Gabapentin
- Esketamine
Other Study ID Numbers
- OMA-AH01
- eudraCT # 2005-003595-38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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