Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
8 August 2016 |
Main ID: |
NCT02653651 |
Date of registration:
|
01/01/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
|
Scientific title:
|
A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study |
Date of first enrolment:
|
January 2016 |
Target sample size:
|
60 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02653651 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
Phase:
|
Phase 4
|
|
Countries of recruitment
|
Tunisia
| | | | | | | |
Contacts
|
Name:
|
Ali JENDOUBI |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University Tunis El Manar |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Adult (>/=18)
2. male or female
3. Undergoing elective open nephrectomy
4. General anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
1. Pregnancy and breastfeeding
2. Cognitively impaired (by history)
3. Subject with a history of psychosis
4. Subject known to have significant hepatic disease
5. History of previous cardiac arrhythmia
6. Subject for whom opioids or ketamine are contraindicated
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Postoperative Pain
|
Intervention(s)
|
Drug: Ketamine
|
Drug: Lidocaine
|
Drug: Placebo
|
Primary Outcome(s)
|
Total opioid consumption
[Time Frame: 24 hours]
|
Secondary Outcome(s)
|
chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)
[Time Frame: At 3 months]
|
Functional recovery assessed by 6 minute walk test (6MWT)
[Time Frame: the fourth postoperative morning]
|
Postoperative nausea and vomiting using a Verbal Rating Scale
[Time Frame: 48 hours]
|
Secondary ID(s)
|
UTuniselmanar
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|