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Colorectal CancerNCT00229567

Intra-op Lidocaine and Ketamine Effect on Postoperative Bowel Function

A study testing Lidocaine infusion plus ketamine injection in people with Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Lidocaine infusion plus ketamine injection
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteCanada
Study dates
Sep 2005to Nov 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Saskatoon Health Region, 410 22nd Street East

    Saskatoon, Saskatchewan, S7K 5T6

Other trials in Canada

About this study

Official title: A Randomised Controlled Trial of Lidocaine Infusion Plus Ketamine Injection Versus Placebo to Decrease Postoperative Ileus

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.

Read the 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.

Being tested
Lidocaine infusion plus ketamine injection
Keywords
ketamine, lidocaine, postoperative ileus, randomized controlled trial, acute postoperative pain
Medical subject headings
Colorectal Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine infusion plus ketamine injectionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (6)
  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Study completionNov 2006

Why it stopped: insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229567
Sponsor's protocol ID
Bio-REB 03-1316
Status last verified
Apr 2007
First submitted
27 Sep 2005
Last updated
19 Apr 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine infusion plus ketamine injection in people with Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean time after surgery to completion of the following postoperative markers:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.

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