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Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine infusion plus ketamine injection
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring ketamine, lidocaine, postoperative ileus, randomized controlled trial, acute postoperative pain

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saskatoon Health Region, 410 22nd Street East

Outcomes

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

Full Information

First Posted
September 27, 2005
Last Updated
April 18, 2007
Sponsor
University of Saskatchewan
Collaborators
Saskatoon Health Region
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1. Study Identification

Unique Protocol Identification Number
NCT00229567
Brief Title
Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function
Official Title
A Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection Versus Placebo to Decrease Postoperative Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatoon Health Region

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
ketamine, lidocaine, postoperative ileus, randomized controlled trial, acute postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lidocaine infusion plus ketamine injection
Primary Outcome Measure Information:
Title
Mean time after surgery to completion of the following postoperative markers:
Title
drinking and retaining 500ml clear fluids,
Title
presence of bowel sounds
Title
passage of flatus, and
Title
passage of stool.
Secondary Outcome Measure Information:
Title
pain after cough by VAS
Title
narcotic usage
Title
nausea
Title
vomiting
Title
infection, dehiscence and other surgical complications
Title
time to readiness for discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William PS McKay, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saskatoon Health Region, 410 22nd Street East
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 5T6
Country
Canada

12. IPD Sharing Statement

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Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

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