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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine infused at 0.1 mg/kg/hour
  • Lidocaine (DRUG)
    Lidocaine infused at 1 mg/kg/hour
  • Placebo (DRUG)
    An equal volume of saline

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2016
    Primary Completion: Jul 01, 2016 ACTUAL
    Completion Date: Jul 01, 2016 ACTUAL
    Study First Posted: Jan 12, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 26, 2016

    Sponsors / Collaborators

    Lead Sponsor: University Tunis El Manar
    Responsible Party: N/A

    Location

    Tunis, Tunisia

    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.

    Participant Groups

    • Ketamine infused at 0.1 mg/kg/hour

    • Lidocaine infused at 1 mg/kg/hour

    • An equal volume of saline

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • the total amount of morphine consumed during follow up period

    Secondary Outcomes

    • 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) the fourth postoperative morning
    • chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4) At 3 months

    More Details

    NCT Number: NCT02653651
    Other IDs: UTuniselmanar
    Study URL: https://clinicaltrials.gov/study/NCT02653651
    Last updated: Sep 29, 2023