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Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Saskatoon Health Region
Information provided by:
University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 29, 2005
Last Update Posted Date April 19, 2007
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
Mean time after surgery to completion of the following postoperative markers: 1)drinking and retaining 500ml clear fluids, 2)presence of bowel sounds 3)passage of flatus, and 4) passage of stool.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • pain after cough by VAS
  • narcotic usage
  • nausea
  • vomiting
  • infection, dehiscence and other surgical complications
  • time to readiness for discharge from hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • - pain after cough by VAS
  • - narcotic usage
  • - nausea
  • - vomiting
  • - infection, dehiscence and other surgical complications
  • - time to readiness for discharge from hospital
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function
Official Title  ICMJE A Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection Versus Placebo to Decrease Postoperative Ileus
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Lidocaine infusion plus ketamine injection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 27, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00229567
Other Study ID Numbers  ICMJE Bio-REB 03-1316
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Saskatoon Health Region
Investigators  ICMJE
Principal Investigator: William PS McKay, MD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP