Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Phase 4

• Conditions: Cholecystolithiasis

• Registration Number: NCT00209885
• Lead Sponsor: Hvidovre University Hospital

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 Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Last Update Submitted: 2005-09-14
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21
• Study Start: 2005-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Degree of nursing requirements in the PACU
2. General tolerability of the regimens

Trial Locations

Locations (1)

Dept of Anaesthesia, Hvidovre Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark