Optimal Multimodal Analgesia in Abdominal Hysterectomy
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ClinicalTrials.gov Identifier: NCT00209872 |
Recruitment Status : Unknown
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 21, 2005
Last Update Posted : November 7, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Planned Abdominal Hysterectomy | Drug: Gabapentin Drug: Lidocaine Drug: S-ketamine Procedure: Epidural analgesia | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | October 2005 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209872
Contact: Kenneth Jensen, M.D. | +45 36 32 62 90 | kenneth.jensen@hh.hosp.dk |
Denmark | |
Dept. of Anaesthesia, Hvidovre Hospital | |
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. |
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 |
ClinicalTrials.gov Identifier: | NCT00209872 |
Other Study ID Numbers: |
OMA-AH01 eudraCT # 2005-003595-38 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | November 7, 2007 |
Last Verified: | September 2005 |
Lidocaine Ketamine Gabapentin Esketamine 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 Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Antimanic Agents Antidepressive Agents |