Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
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...
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
- Drug: S-ketamine
- Drug: Lidocaine
- Drug: Droperidol
Outcome Measures for this Clinical Trial
Primary Measures
- 1. postoperative abilities over time in PACU
- 2. discharge time from PACU according to fixed criteria
- 3. consumption of analgesics and antiemetics in the PACU
Secondary Measures
- 1. Degree of nursing requirements in the PACU
- 2. General tolerability of the regimens
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hvidovre University Hospital Other
Overall Clinical Trial Officials and Contacts
Kenneth Jensen, M.D. Principal Investigator Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Overall Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209885
Study ID Number: OMA-LC01
ClinicalTrials.gov Identifier: NCT00209885
Health Authority: Denmark: Danish Medicines Agency
URL looking into anaesthesia and surgery for cholecystectomy
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00209885
