Lidocaine and Ketamine in Abdominal Surgery

NCT ID: NCT00721110

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-07-31

Brief Summary

This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.

Detailed Description

Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.

Conditions

Abdominal Hysterectomy (& Wertheim)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.

Placebo

A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo boluses and infusions will be substituted

Ketamine

Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.

ketamine + Lidocaine

both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.

Group Type: ACTIVE_COMPARATOR

Ketamine + Lidocaine

Intervention Type: DRUG

both Ketamine and Lidocaine will be given

Interventions

Lidocaine

Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.

Intervention Type: DRUG

Placebo

Placebo boluses and infusions will be substituted

Intervention Type: DRUG

Ketamine

Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.

Intervention Type: DRUG

Ketamine + Lidocaine

both Ketamine and Lidocaine will be given

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age greater than 18 years old and less than 75 years years old
• Horizontal abdominal incision

Exclusion Criteria

• Emergency or urgent procedure
• Preexisting chronic pain (at any site) requiring treatment
• Contraindication to any study medication (ketamine or lidocaine)
• History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
• Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
• Seizure disorder requiring medication within past 2 years
• Planned spinal or epidural anesthesia or analgesia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Grady, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic/Hillcrest Hospital

Mayfield Heights, Ohio, United States

Countries

United States

Other Identifiers

08-454

Identifier Type: -

Identifier Source: org_study_id