Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain - Full Text View

Sponsored by:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00720330

Purpose

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.

Condition	Intervention
Pain Nausea	Drug: ropivacaine Drug: Lidocaine/Ketamine Other: placebo

MedlinePlus related topics: Anesthesia Nausea and Vomiting

Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Propofol Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Lidocaine Ketamine Ketamine hydrochloride Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

Postoperative analgesic consumption in oral oxycodone equivalents [ Time Frame: 3 and 6 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pre and intraoperative analgesic consumption in fentanyl equivalents [ Time Frame: 3 and 6 months post-operatively ] [ Designated as safety issue: No ]
Time from end of surgery to readiness for hospital discharge. [ Time Frame: number of days to hospital discharge ] [ Designated as safety issue: No ]
Verbal response pain scores [ Time Frame: PACU admission and discharge,first and second postoperative mornings. ] [ Designated as safety issue: No ]
Incidence of postoperative nausea [ Time Frame: Day 1 and day 2 post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	486
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator 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	Drug: 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
Group 2: Active Comparator 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.	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).
Group 3: Placebo Comparator General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery	Other: placebo placebo

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than 18 and less than 75 years
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720330

Contacts

Contact: Kenneth Cummings, MD	440-312-5259	cummink2@ccf.org
Contact: Nancy Graham, BA.CCRP	216-445-7530	grahamn@ccf.org

Locations

United States, Ohio
Cleveland Clinic/Hillcrest Hospital	Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Kenneth Cummings, MD 440-312-5259 cummink2@ccf.org

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:	Kenneth Cummings, MD	Cleveland Clinic
Study Chair:	Daniel I Sessler, MD	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( Kenneth Cummings, MD )
Study ID Numbers:	08-385
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720330
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

Inguinal Herniorrhaphy
Pain assessment
Outcomes

Study placed in the following topic categories:

Excitatory Amino Acids
Fentanyl
Ropivacaine
Ketamine
Lidocaine

Nausea
Pain
Epinephrine
Propofol
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics, Dissociative

Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009