Optimal Multimodal Analgesia in Abdominal Hysterectomy
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).
Intervention / Treatment
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Gabapentin (DRUG)N/A
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Lidocaine (DRUG)N/A
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S-ketamine (DRUG)N/A
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Epidural analgesia (PROCEDURE)N/A
Condition or Disease
- Planned Abdominal Hysterectomy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 60 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Oct 01, 2005 | |
|---|---|---|
| Primary Completion: | Aug 31, 2020 | |
| Completion Date: | Aug 31, 2020 | |
| Study First Posted: | Sep 21, 2005 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Nov 06, 2007 |
Sponsors / Collaborators
Location
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
* 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
Eligibility Criteria
| Sex: | Female |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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Postoperative abilities over time
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Discharge time from PACU according to fixed criteria
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Consumption of analgesics and antiemetics in the PACU
Secondary Outcomes
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Degree of nursing requirements at the PACU
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General tolerability of the regimes
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Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
More Details
| NCT Number: | NCT00209872 |
|---|---|
| Other IDs: | OMA-AH01 |
| Study URL: | https://clinicaltrials.gov/study/NCT00209872 |
Last updated: Sep 29, 2023