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Trial record 86 of 317 for:    colon cancer | ( Map: Canada )

Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229567
Recruitment Status : Terminated (insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.)
First Posted : September 29, 2005
Last Update Posted : April 19, 2007
Saskatoon Health Region
Information provided by:
University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Lidocaine infusion plus ketamine injection Not Applicable

Detailed Description:

Introduction: Postoperative ileus is a normal response to the surgical handling of bowel that causes transient impairment of bowel motility after abdominal surgery. It is characterized by distension, absence of bowel sounds, and lack of passage of flatus and stool. The duration of postoperative ileus is related to the degree of surgical manipulation and the location of surgery. Colonic surgery is associated with the longest duration of ileus. Morphine patient-controlled intravenous analgesia (PCIA) is commonly used to provide pain control after bowel surgery. The bowel wall contains opiate receptors that decrease bowel peristalsis in the presence of morphine. Thus, both surgery and PCIA slow return of normal bowel function.

Lidocaine and ketamine are non-opioid analgesics that have been shown to be safe and efficacious in low doses when combined with morphine for post-operative pain control. Since the addition of lidocaine or ketamine to a morphine PCIA regimen results in lower total use of morphine, and since lidocaine or ketamine does not slow peristalsis, , it is reasonable to expect that low-dose lidocaine or ketamine plus PCIA morphine will result in faster return of bowel function than PCIA morphine alone.

Intravenous lidocaine was first shown to relieve cancer pain in the 1950s. Since then, intravenous lidocaine has been shown also to relieve pain after a wide variety of surgeries. Ketamine is a non-opioid analgesic that has been shown to be safe and efficacious in very low doses when combined with morphine for post-operative pain control . A review of ketamine for postoperative pain control recently completed by Dr McKay has shown that ketamine is most efficacious when given after a painful surgical insult, and that preoperative bezodiazepines prevent ketamine-induced hallucinations (submitted for publication). Groudine, in patients undergoing radical retropubic prostatectomy, determined that intravenous lidocaine infusion intraoperatively decreased the duration of postoperative ileus, decreased the pain scores postoperatively, and resulted in a 50% reduction in morphine use, and a 20% reduction in hospitalization time. This was felt to be due to early ambulation, earlier times to passing gas and having a bowel movement, and faster advancement to a full diet and oral analgesics. Lidocaine plasma levels were well below toxic range.

We propose a double-blind placebo-controlled study of patients undergoing elective or urgent colon surgery with an anastomotic procedure. All patients will receive normal PCA morphine in addition to study drugs or placebo. Research will be conducted at Saskatoon teaching hospitals. This procedure was chosen as it is associated with a longer duration of ileus compared to other abdominal surgeries and more likely to show a significant treatment effect.

If previous data is applicable to colonic surgery then we can expect a decrease in postoperative analgesic requirements, earlier return of bowel function, earlier progression to full diet and earlier discharge dates.

The dose of lidocaine we propose has been shown to be safe in thousands of patients for whom it was used to treat arrhythmias; that of ketamine in more than twenty studies of postoperative pain control.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection Versus Placebo to Decrease Postoperative Ileus
Study Start Date : September 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mean time after surgery to completion of the following postoperative markers:
  2. drinking and retaining 500ml clear fluids,
  3. presence of bowel sounds
  4. passage of flatus, and
  5. passage of stool.

Secondary Outcome Measures :
  1. pain after cough by VAS
  2. narcotic usage
  3. nausea
  4. vomiting
  5. infection, dehiscence and other surgical complications
  6. time to readiness for discharge from hospital

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00229567

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Canada, Saskatchewan
Saskatoon Health Region, 410 22nd Street East
Saskatoon, Saskatchewan, Canada, S7K 5T6
Sponsors and Collaborators
University of Saskatchewan
Saskatoon Health Region
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Principal Investigator: William PS McKay, MD University of Saskatchewan

Layout table for additonal information Identifier: NCT00229567     History of Changes
Other Study ID Numbers: Bio-REB 03-1316
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007
Keywords provided by University of Saskatchewan:
postoperative ileus
randomized controlled trial
acute postoperative pain
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents