Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

NCT00229567 | Terminated

• 1 other identifier: Bio-REB 03-1316
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Bowel function after bowel surgery is delayed (postoperative ileus)by both opiates and the surgery itself. We hypothesized that decreasing opiate use by other analgesics will speed the return of bowel function after surgery. Lidocaine and Ketamine are drugs that appear to be synergistic and do not slow peristalsis. This study is a Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection versus Placebo to to determine whether they will decrease opiate use and then whether decreased opiate use will speed the return of bowel function.

Conditions

Colorectal Cancer

Keywords

ketamine; lidocaine; postoperative ileus; randomized controlled trial; acute postoperative pain

Outcome Measures

Primary Outcomes (5)

• Mean time after surgery to completion of the following postoperative markers:

• drinking and retaining 500ml clear fluids,

• presence of bowel sounds

• passage of flatus, and

• passage of stool.

Secondary Outcomes (6)

• pain after cough by VAS

• narcotic usage

• nausea

• vomiting

• infection, dehiscence and other surgical complications

Interventions

Lidocaine infusion plus ketamine injection DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 79
• booked for urgent or elective colon surgery undergoing a left, right, or transverse hemicolectomy via laparotomy

You may not qualify if:

• patients requiring emergency surgery
• pregnant subjects or those who might be pregnant
• subjects allergic to lidocaine, ketamine, morphine, naproxen, or acetaminophen
• subjects with epidural analgesia
• subjects unable to understand and implement a Patient-Controlled Intravenous Analgesia system
• subjects who do not know English well enough to understand the consent form and assessments
• subjects with known hepatic or renal failure or cardiac dysrhythmias or atrioventricular block
• patients with pre-existing functional bowel motility disorders including Crohn's disease and ulcerative colitis
• daily use of laxatives, inability to have a bowel movement without laxatives, use of suppositories or enemas on a daily basis, or use of antimotility agents
• patients with Parkinson's disease

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatoon Health Region: collaborator

Study Sites (1)

Saskatoon Health Region, 410 22nd Street East

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• William PS McKay, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2006
• Last Updated: April 19, 2007

Record last verified: 2007-04

Locations

CA (1)