Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

NCT ID: NCT00720330

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-02-28

Brief Summary

The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.

Detailed Description

Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments

Conditions

Pain; Nausea

Study Design

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

Study Groups

Ropivacaine

Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation

Group Type: ACTIVE_COMPARATOR

ropivacaine

Intervention Type: DRUG

10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation

Lidocaine/ketamine

Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.

Group Type: ACTIVE_COMPARATOR

Lidocaine/Ketamine

Intervention Type: DRUG

Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).

Placebo

General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo

Interventions

ropivacaine

10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation

Intervention Type: DRUG

Lidocaine/Ketamine

Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).

Intervention Type: DRUG

placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than 18 and less than 75 years
• Male
• Unilateral inguinal hernia scheduled for elective open repair

Exclusion Criteria

• Incarcerated hernia or urgent procedure
• Reoperation (recurrent hernia)
• Contraindication to regional anesthesia such as:
• Coagulopathy
• Infection at the site of needle insertion
• Pre-existing chronic pain (at any site) requiring treatment
• Contraindication to any study medication (local anesthetic or ketamine)
• 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

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

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Cummings III, MD, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Cummings, 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

08-385

Identifier Type: -

Identifier Source: org_study_id