Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Cholecystolithiasis

Treatments: Drug: Lidocaine; Drug: Gabapentin; Drug: Droperidol; Drug: S-ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00209885

OMA-LC01

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind