Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

This study has been terminated.
(insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.)
Sponsor:
Collaborator:
Saskatoon Health Region
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00229567
First received: September 27, 2005
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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 Intervention
Colorectal Cancer
Drug: Lidocaine infusion plus ketamine injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection Versus Placebo to Decrease Postoperative Ileus

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • pain after cough by VAS
  • narcotic usage
  • nausea
  • vomiting
  • infection, dehiscence and other surgical complications
  • time to readiness for discharge from hospital

Estimated Enrollment: 60
Study Start Date: September 2005
Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229567

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

No publications provided

ClinicalTrials.gov Identifier: NCT00229567     History of Changes
Other Study ID Numbers: Bio-REB 03-1316
Study First Received: September 27, 2005
Last Updated: April 18, 2007
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:
ketamine
lidocaine
postoperative ileus
randomized controlled trial
acute postoperative pain

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Ketamine
Lidocaine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on July 20, 2014