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
|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
|Original Primary Outcome Measures ICMJE
||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.|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|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.|
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
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 Status ICMJE||Terminated|
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||November 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|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|
|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|
|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