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

NCT02653651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-28

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

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

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Principal Investigators

  • Ali JENDOUBI · University Tunis El Manar

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Tunisia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653651 on ClinicalTrials.gov