Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

April 1, 2021

Study Completion Date

April 1, 2021

Conditions
Pain, Postoperative
Interventions
DRUG

Lidocaine Hydrochloride

The intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

DRUG

Saline Solution

The intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

Trial Locations (1)

9007

Cantonal Hospital of St. Gallen, Sankt Gallen

All Listed Sponsors
lead

Miodrag Filipovic, Prof. Dr. med.

OTHER

NCT03667001 - Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery | Biotech Hunter | Biotech Hunter