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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044808
• Other study ID #: 13.024
• Secondary ID: 2014-003466-25
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2017
• Last updated: September 18, 2017
• Start date: February 2, 2016
• Est. completion date: April 19, 2017

Study information

• Verified date: September 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Lidocaine

• Saline

Locations

Country	Name	City	State
Denmark	Odense Universitetshospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in morphine consumption	PCA morphine added to PN (per necessitae) morphine, cumulated	over the first 24 hours
Secondary	PONV	Postoperative nausea and vomiting - patient is asked	up to 72 hours
Secondary	Reduction in morphine consumption	PCA morphine added to PN morphine, cumulated	over the first 72hours
Secondary	Use of antiemetics postoperative		first 72 hours
Secondary	Time to bowel function	time to flatus or defecation or function of bowel stoma	first 72 hours
Secondary	time to discharge		up to 72 hours