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Optimal Multimodal Analgesia in Abdominal Hysterectomy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Hvidovre University Hospital
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00209872
First received: September 14, 2005
Last updated: November 6, 2007
Last verified: September 2005
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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 | Intervention | Phase |
|---|---|---|
| Planned Abdominal Hysterectomy | Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- Postoperative abilities over time
- Discharge time from PACU according to fixed criteria
- Consumption of analgesics and antiemetics in the PACU
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
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00209872
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209872
Contacts
| Contact: Kenneth Jensen, M.D. | +45 36 32 62 90 | kenneth.jensen@hh.hosp.dk |
Locations
| Denmark | |
| Dept. of Anaesthesia, Hvidovre Hospital | Not yet recruiting |
| 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. | |
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
| Principal Investigator: | Kenneth Jensen, M.D. | Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark |
| Study Chair: | Claus Lund, Dr. Med. Sci. | Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00209872 History of Changes |
| Other Study ID Numbers: |
OMA-AH01 eudraCT # 2005-003595-38 |
| Study First Received: | September 14, 2005 |
| Last Updated: | November 6, 2007 |
Additional relevant MeSH terms:
|
Lidocaine Ketamine Gabapentin Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Analgesics |
Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Antimanic Agents |
ClinicalTrials.gov processed this record on June 26, 2017