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OpenTrials
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NCT Number: NCT02653651

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

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.

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Key information

Conditions

Postoperative Pain Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Saline

Primary outcomes

  1. Total opioid consumption

    Time frame: 24 hours

    the total amount of morphine consumed during follow up period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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