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, 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

Further Study Details: 

Primary Outcomes: Postoperative abilities over time; Discharge time from PACU according to fixed criteria; Consumption of analgesics and antiemetics in the PACU
Secondary Outcomes: Degree of nursing requirements at the PACU; General tolerability of the regimes; Threshold for sensory perception and pain using the PainMatcher device, pre- and postoperatively
Expected Total Enrollment:  60

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Planned abdominal hysterectomy with or without BSO
• Age above 18 years
• Written informed consent
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00209872

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

Denmark, Hvidovre
      Dept of Anaesthesia, Hvidovre Hospital, Copenhagen,  Hvidovre,  2650,  Denmark

Study chairs or principal investigators

Kenneth Jensen, M.D.,  Principal Investigator,  Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark   
Claus Lund, dr.med.sci.,  Study Chair,  Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark   

Study ID Numbers:  OMA-AH01; eudraCT # 2005-003595-38
Last Updated:  September 20, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00209872
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-27