Optimal Multimodal Analgesia in Abdominal Hysterectomy | RxWiki

Optimal Multimodal Analgesia in Abdominal Hysterectomy

Overview[ - collapse ][ - ]

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	Planned Abdominal Hysterectomy
Intervention	Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia
Phase	Phase 4
Sponsor	Hvidovre University Hospital
Responsible Party	Hvidovre University Hospital
ClinicalTrials.gov Identifier	NCT00209872
First Received	September 14, 2005
Last Updated	November 6, 2007
Last verified	September 2005

Tracking Information[ + expand ][ + ]

First Received Date	September 14, 2005
Last Updated Date	November 6, 2007
Start Date	October 2005
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Postoperative abilities over time Discharge time from PACU according to fixed criteria Consumption of analgesics and antiemetics in the PACU
Current 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

Descriptive Information[ + expand ][ + ]

Brief Title	Optimal Multimodal Analgesia in Abdominal Hysterectomy
Official Title	Not Provided
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).
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
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition	Planned Abdominal Hysterectomy
Intervention	Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	60
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
Eligibility 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk
Location Countries	Denmark

Administrative Information[ + expand ][ + ]

NCT Number	NCT00209872
Other Study ID Numbers	OMA-AH01
Has Data Monitoring Committee	Not Provided
Information Provided By	Hvidovre University Hospital
Study Sponsor	Hvidovre University Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Kenneth Jensen, M.D. Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, DenmarkStudy Chair: Claus Lund, Dr. Med. Sci. Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
Verification Date	September 2005

Locations[ + expand ][ + ]

Dept. of Anaesthesia, Hvidovre Hospital	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. Not yet recruiting