Optimal Multimodal Analgesia in Abdominal Hysterectomy

Phase 4

• Conditions: Planned Abdominal Hysterectomy

• Registration Number: NCT00209872
• Lead Sponsor: Hvidovre University Hospital

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 Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Study Start: 2005-10
• Last Update Submitted: 2007-11-06
• Last Update Posted: 2007-11-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Anaesthesia, Hvidovre Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark