Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
Overview[ - collapse ][ - ]
| Purpose | To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU |
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| Condition | Cholecystolithiasis |
| Intervention | Drug: Gabapentin Drug: S-ketamine Drug: Lidocaine Drug: Droperidol |
| Phase | Phase 4 |
| Sponsor | Hvidovre University Hospital |
| Responsible Party | Hvidovre University Hospital |
| ClinicalTrials.gov Identifier | NCT00209885 |
| First Received | September 14, 2005 |
| Last Updated | September 14, 2005 |
| Last verified | September 2005 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 14, 2005 |
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| Last Updated Date | September 14, 2005 |
| Start Date | October 2005 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy |
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| Official Title | Not Provided |
| Brief Summary | To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU |
| Detailed Description | Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups: - A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium - B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol. Primary endpoints: - postoperative abilities over time - discharge time from PACU according to fixed criteria - consumption of analgesics and antiemetics in the PACU Secondary endpoints: - degree of nursing requirements at the PACU - General tolerability of the regimes |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Cholecystolithiasis |
| Intervention | Drug: Gabapentin Drug: S-ketamine Drug: Lidocaine Drug: Droperidol |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 60 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Elective laparoscopic cholecystectomy - Age above 18 years - Written informed consent - ASA class I-III Exclusion Criteria: - Planned abdominal cholecystectomy - Intraoperative conversion of laparoscopic to laparotomic cholecystectomy - Allergy to part of the treatment regimens - Previous reactions to opioids (nausea, cognition) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk |
| Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00209885 |
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| Other Study ID Numbers | OMA-LC01 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hvidovre University Hospital |
| Study Sponsor | Hvidovre University Hospital |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Kenneth Jensen, M.D. Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, DenmarkStudy Chair: Claus Lund, dr.med.sci Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark |
| Verification Date | September 2005 |
Locations[ + expand ][ + ]
| Dept of Anaesthesia, Hvidovre Hospital | Copenhagen, Hvidovre, Denmark, 2650 Contact: Kenneth Jensen, M.D. | +45 36 32 62 90 | kenneth.jensen@hh.hosp.dkPrincipal Investigator: Kenneth Jensen, M.D. Not yet recruiting |
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