Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery
This study has been completed.
Sponsor:
Kangbuk Samsung Hospital
Information provided by (Responsible Party):
HO Kim, MD, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT01346917
First received: April 29, 2011
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Drug: Lidocaine Drug: Normal saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by Kangbuk Samsung Hospital:
Primary Outcome Measures:
- Prevalence of postoperative nausea and vomiting. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Time to first flatus. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
- Time to first passage of stool. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
- Degree of postoperative pain. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
- Postoperative opioid consumption. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
- Time to tolerance of regular diet [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
- Postoperative complications [ Time Frame: From day of surgery to thirtieth postoperative day. ] [ Designated as safety issue: No ]
- Duration of postoperative hospital stay. [ Time Frame: From day of surgery until discharge, an expected average of nine days. ] [ Designated as safety issue: No ]
| Enrollment: | 77 |
| Study Start Date: | April 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lidocaine |
Drug: Lidocaine
Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
|
| Placebo Comparator: Placebo |
Drug: Normal saline
Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elective laparoscopic colorectal surgery for colorectal cancer.
- Age > 18 years.
- Informed consent.
Exclusion Criteria:
- Allergy to local anesthetics.
- Severe cardiovascular, hepatic, or renal diseases.
- Pregnant or lactating patients.
- Emergency surgery.
- American Society of Anesthesiologists (ASA) class IV
Contacts and Locations More Information
No publications provided
| Responsible Party: | HO Kim, MD, Assistant professor, Kangbuk Samsung Hospital |
| ClinicalTrials.gov Identifier: | NCT01346917 History of Changes |
| Other Study ID Numbers: | KHO10-1 |
| Study First Received: | April 29, 2011 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Kangbuk Samsung Hospital:
|
Colorectal cancer Laparoscopic surgery Postoperative ileus Lidocaine Early oral feeding |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Lidocaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013