Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Ketamine
Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring Ketamine, Lidocaine, Nephrectomy, Chronic pain
Eligibility Criteria
Inclusion Criteria:
- Adult (>/=18)
- male or female
- Undergoing elective open nephrectomy
- General anesthesia
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
- Pregnancy and breastfeeding
- Cognitively impaired (by history)
- Subject with a history of psychosis
- Subject known to have significant hepatic disease
- History of previous cardiac arrhythmia
- Subject for whom opioids or ketamine are contraindicated
Sites / Locations
- Ali JENDOUBI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Ketamine
Lidocaine
Placebo
Arm Description
Ketamine infused at 0.1 mg/kg/hour
Lidocaine infused at 1 mg/kg/hour
An equal volume of saline
Outcomes
Primary Outcome Measures
Total opioid consumption
the total amount of morphine consumed during follow up period
Secondary Outcome Measures
Postoperative nausea and vomiting using a Verbal Rating Scale
Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale
Functional recovery assessed by 6 minute walk test (6MWT)
chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)
Full Information
NCT ID
NCT02653651
First Posted
January 1, 2016
Last Updated
July 26, 2016
Sponsor
University Tunis El Manar
1. Study Identification
Unique Protocol Identification Number
NCT02653651
Brief Title
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.
Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.
The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.
Detailed Description
Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Ketamine, Lidocaine, Nephrectomy, Chronic pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine infused at 0.1 mg/kg/hour
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine infused at 1 mg/kg/hour
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An equal volume of saline
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine infused at 0.1 mg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine infused at 1 mg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
An equal volume of saline
Primary Outcome Measure Information:
Title
Total opioid consumption
Description
the total amount of morphine consumed during follow up period
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting using a Verbal Rating Scale
Description
Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale
Time Frame
48 hours
Title
Functional recovery assessed by 6 minute walk test (6MWT)
Time Frame
the fourth postoperative morning
Title
chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (>/=18)
male or female
Undergoing elective open nephrectomy
General anesthesia
Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
Pregnancy and breastfeeding
Cognitively impaired (by history)
Subject with a history of psychosis
Subject known to have significant hepatic disease
History of previous cardiac arrhythmia
Subject for whom opioids or ketamine are contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali JENDOUBI
Organizational Affiliation
University Tunis El Manar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ali JENDOUBI
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
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