Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2005-10-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Gabapentin
Lidocaine
S-ketamine
Epidural analgesia
Eligibility Criteria
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Inclusion Criteria
* Age above 18 years
* Written informed consent
* American Society of Anesthesiologists (ASA) class I-III
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Hvidovre University Hospital
OTHER
Principal Investigators
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Kenneth Jensen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Claus Lund, Dr. Med. Sci.
Role: STUDY_CHAIR
Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
Locations
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Dept. of Anaesthesia, Hvidovre Hospital
Copenhagen, Hvidovre, Denmark
Countries
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Central Contacts
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Facility Contacts
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Kenneth Jensen, M.D.
Role: primary
Related Links
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URL looking into anaesthesia and surgery for abdominal hysterectomy
Other Identifiers
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eudraCT # 2005-003595-38
Identifier Type: -
Identifier Source: secondary_id
OMA-AH01
Identifier Type: -
Identifier Source: org_study_id