Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653651
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ali JENDOUBI, University Tunis El Manar

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketamine Drug: Lidocaine Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Ketamine
Ketamine infused at 0.1 mg/kg/hour
Drug: Ketamine
Ketamine infused at 0.1 mg/kg/hour

Experimental: Lidocaine
Lidocaine infused at 1 mg/kg/hour
Drug: Lidocaine
Lidocaine infused at 1 mg/kg/hour

Placebo Comparator: Placebo
An equal volume of saline
Drug: Placebo
An equal volume of saline
Other Name: Saline




Primary Outcome Measures :
  1. Total opioid consumption [ Time Frame: 24 hours ]
    the total amount of morphine consumed during follow up period


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 48 hours ]
    Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale

  2. Functional recovery assessed by 6 minute walk test (6MWT) [ Time Frame: the fourth postoperative morning ]
  3. chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4) [ Time Frame: At 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653651


Locations
Layout table for location information
Tunisia
Ali JENDOUBI
Tunis, Tunisia, 1006
Sponsors and Collaborators
University Tunis El Manar
Investigators
Layout table for investigator information
Principal Investigator: Ali JENDOUBI University Tunis El Manar

Layout table for additonal information
Responsible Party: Ali JENDOUBI, MD, Assistant Professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT02653651     History of Changes
Other Study ID Numbers: UTuniselmanar
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ali JENDOUBI, University Tunis El Manar:
Ketamine
Lidocaine
Nephrectomy
Chronic pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents