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

Postoperative Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653651
• Other study ID #: UTuniselmanar
• Status: Completed
• Phase: Phase 4
• First received: January 1, 2016
• Last updated: July 26, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine
Ketamine infused at 0.1 mg/kg/hour
• Lidocaine
Lidocaine infused at 1 mg/kg/hour
• Placebo
An equal volume of saline

Locations

Country	Name	City	State
Tunisia	Ali JENDOUBI	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption	the total amount of morphine consumed during follow up period	24 hours	Yes
Secondary	Postoperative nausea and vomiting using a Verbal Rating Scale	Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale	48 hours	Yes
Secondary	Functional recovery assessed by 6 minute walk test (6MWT)		the fourth postoperative morning	No
Secondary	chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)		At 3 months	No