Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Opioid Use

Treatments: Drug: Lidocaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03044808

13.024

2014-003466-25 (EudraCT Number)

Details and patient eligibility

About

Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at 24 hours.

Full description

Prospective double blind randomised controlled trial. The investigators are giving lidocaine IV or saline to 60 patients undergoing robot assisted colorectal surgery. Blinding and randomization is done by the hospital pharmacy. Both groups get otherwise the same treatment and a IV PCA (patient controlled administration) morphine pump for objectivisation of opioid consumption. Other outcome measures are NRS (numerical rating score) pain score, PONV (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients due to robotic laparoscopic colorectal surgery, > 18years of age, danish speaking

Exclusion criteria

• allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or NSAIDS, pregnancy, breastfeeding women, treatment with betablockers, porphyria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Lidocain

Experimental group

Description:

Patient gets the experimental treatment with IV lidocain 0,5mg/ml, 1,5mg/kg bolus before induction of anesthesia, after that infusion of 1,5mg/kg/h is started and continued until 2 hours after end of surgery.

Treatment:

Drug: Lidocaine

Control

Placebo Comparator group

Description:

Patients get the same amount in ml and duration as if it was the experimental arm. Only in this arm it is isotonic saline instead.

Treatment:

Drug: Saline