Planned Abdominal Hysterectomy
Conditions
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
Interventions
DRUGGabapentin
DRUGLidocaine
DRUGS-ketamine
PROCEDUREEpidural analgesia
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative abilities over time | — |
| Discharge time from PACU according to fixed criteria | — |
| Consumption of analgesics and antiemetics in the PACU | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Primary ContactKenneth Jensen, M.D.
Outcome results
None listed