Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

This study has been terminated.
(Enrollment challenges prohibited study progression.)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00720330
First received: July 21, 2008
Last updated: March 17, 2010
Last verified: March 2010
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 22
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
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
Active Comparator: Group 2
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).
Placebo Comparator: Group 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Kenneth Cummings, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00720330     History of Changes
Other Study ID Numbers: 08-385
Study First Received: July 21, 2008
Last Updated: March 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Inguinal Herniorrhaphy
Pain assessment
Outcomes

Additional relevant MeSH terms:
Nausea
Chronic Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Ketamine
Lidocaine
Ropivacaine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on August 26, 2014