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

NCT02653651 | Completed Phase 4

• 1 other identifier: UTuniselmanar
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Ketamine; Lidocaine; Nephrectomy; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  the total amount of morphine consumed during follow up period

  24 hours

Secondary Outcomes (3)

• Postoperative nausea and vomiting using a Verbal Rating Scale

  48 hours

• 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

Study Arms (3)

Ketamine

ACTIVE COMPARATOR

Ketamine infused at 0.1 mg/kg/hour

Drug: Ketamine

Lidocaine

EXPERIMENTAL

Lidocaine infused at 1 mg/kg/hour

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

An equal volume of saline

Drug: Placebo

Interventions

Ketamine DRUG

Ketamine infused at 0.1 mg/kg/hour

Ketamine

Lidocaine DRUG

Lidocaine infused at 1 mg/kg/hour

Lidocaine

Placebo DRUG

An equal volume of saline

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>/=18)
• male or female
• Undergoing elective open nephrectomy
• General anesthesia
• Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Ketamine; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ali JENDOUBI

  University Tunis El Manar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: January 1, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)