Optimal Multimodal Analgesia in Abdominal Hysterectomy
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)...
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
- Drug: Lidocaine
- Drug: S-ketamine
- Procedure: Epidural analgesia
Outcome Measures for this Clinical Trial
Primary Measures
- Postoperative abilities over time
- Discharge time from PACU according to fixed criteria
- Consumption of analgesics and antiemetics in the PACU
Secondary 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
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hvidovre University Hospital Other
Overall Clinical Trial Officials and Contacts
Kenneth Jensen, M.D. Principal Investigator Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Overall Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209872
Study ID Number: OMA-AH01
ClinicalTrials.gov Identifier: NCT00209872
Health Authority: Denmark: Danish Medicines Agency
URL looking into anaesthesia and surgery for abdominal hysterectomy
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00209872
