Colorectal CancerNCT01346917
Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery
A study testing Lidocaine and Normal saline in people with Colorectal Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer. Degree of nausea/vomiting. Degree of postoperative pain and opioids requirement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Lidocaine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic colorectal surgery for colorectal cancer.
- Age > 18 years.
- Informed consent.
Who cannot join
- Allergy to local anesthetics.
- Severe cardiovascular, hepatic, or renal diseases.
- Pregnant or lactating patients.
- Emergency surgery.
- American Society of Anesthesiologists (ASA) class IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer
The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.
- Degree of nausea/vomiting.
- Degree of postoperative pain and opioids requirement.
- Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.
- Conditions
- Colorectal Cancer
- Being tested
- Lidocaine, Normal saline
- Keywords
- Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
Normal salineDrug
Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Not described Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of postoperative nausea and vomiting.
Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status.
Measured: From day of surgery to sixth postoperative day.
Secondary outcomes (7)
Time to first flatus.
Measured: From day of surgery to sixth postoperative day.
Time to first passage of stool.
Measured: From day of surgery to sixth postoperative day.
Degree of postoperative pain.
Measured: From day of surgery to sixth postoperative day.
Postoperative opioid consumption.
Measured: From day of surgery to sixth postoperative day.
Time to tolerance of regular diet
Measured: From day of surgery to sixth postoperative day.
Postoperative complications
Measured: From day of surgery to thirtieth postoperative day.
Duration of postoperative hospital stay.
Measured: From day of surgery until discharge, an expected average of nine days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HO Kim, MD, Kangbuk Samsung Hospital
- Investigators
- Hyung Ook Kim, M.D, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346917
- Sponsor's protocol ID
- KHO10-1
- Status last verified
- Oct 2012
- First submitted
- 29 Apr 2011
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HO, Lee SR, Choi WJ, Kim H. Early oral feeding following laparoscopic colorectal cancer surgery. ANZ J Surg. 2014 Jul-Aug;84(7-8):539-44. doi: 10.1111/ans.12550. Epub 2014 Feb 24.
PubMed 24612414
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01346917
- Acronym / sponsor ID
- KHO10-1
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.
- Degree of nausea/vomiting.
- Degree of postoperative pain and opioids requirement.
- Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine |
| Placebo | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective laparoscopic colorectal surgery for colorectal cancer.
- Age > 18 years.
- Informed consent.
Key exclusion criteria (5 listed)
- Allergy to local anesthetics.
- Severe cardiovascular, hepatic, or renal diseases.
- Pregnant or lactating patients.
- Emergency surgery.
- American Society of Anesthesiologists (ASA) class IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs. | Drug | Lidocaine |
| Normal salineNormal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs. | Drug | Placebo |
Primary outcome
Prevalence of postoperative nausea and vomiting.
Time frame: From day of surgery to sixth postoperative day.
Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status.
7 secondary outcomes
Time to first flatus.
Time frame: From day of surgery to sixth postoperative day.
Time to first passage of stool.
Time frame: From day of surgery to sixth postoperative day.
Degree of postoperative pain.
Time frame: From day of surgery to sixth postoperative day.
Postoperative opioid consumption.
Time frame: From day of surgery to sixth postoperative day.
Time to tolerance of regular diet
Time frame: From day of surgery to sixth postoperative day.
Postoperative complications
Time frame: From day of surgery to thirtieth postoperative day.
Duration of postoperative hospital stay.
Time frame: From day of surgery until discharge, an expected average of nine days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
- Derived from this study: PubMed 24612414Kim HO, Lee SR, Choi WJ, Kim H. Early oral feeding following laparoscopic colorectal cancer surgery. ANZ J Surg. 2014 Jul-Aug;84(7-8):539-44. doi: 10.1111/ans.12550. Epub 2014 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Ook Kim, M.D principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal saline in people with Colorectal Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Oct 2012. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of postoperative nausea and vomiting. (time frame: From day of surgery to sixth postoperative day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346917, which also lists 1 linked publication.
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 17 Oct 2012.