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

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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

Tracking Information
First Submitted Date  ICMJE January 1, 2016
First Posted Date  ICMJE January 12, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
Total opioid consumption [ Time Frame: 24 hours ]
the total amount of morphine consumed during follow up period
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2016)
Total opioid consumption [ Time Frame: 48 hours ]
the total amount of morphine consumed during follow up period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2016)
  • 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
  • Functional recovery assessed by 6 minute walk test (6MWT) [ Time Frame: the fourth postoperative morning ]
  • chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4) [ Time Frame: At 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine infused at 0.1 mg/kg/hour
  • Drug: Lidocaine
    Lidocaine infused at 1 mg/kg/hour
  • Drug: Placebo
    An equal volume of saline
    Other Name: Saline
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Ketamine infused at 0.1 mg/kg/hour
    Intervention: Drug: Ketamine
  • Experimental: Lidocaine
    Lidocaine infused at 1 mg/kg/hour
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    An equal volume of saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653651
Other Study ID Numbers  ICMJE UTuniselmanar
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ali JENDOUBI, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali JENDOUBI University Tunis El Manar
PRS Account University Tunis El Manar
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP