Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

• ClinicalTrials.gov Identifier: NCT00720330
• Recruitment Status: Terminated
• First Posted: July 22, 2008
• Results First Posted: May 19, 2017
• Last Update Posted: March 12, 2019
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Kenneth Cummings III, MD, MS, The Cleveland Clinic

Tracking Information

• First Submitted Date: July 21, 2008
• First Posted Date: July 22, 2008
• Results First Submitted Date: April 14, 2017
• Results First Posted Date: May 19, 2017
• Last Update Posted Date: March 12, 2019
• Study Start Date: July 2008
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2017)

Postoperative Opioid Consumption in Oral Oxycodone Equivalents [ Time Frame: 2 days after surgery ]

The cumulative opioid consumption after surgery until the end of second postoperative day.

• Original Primary Outcome Measures (submitted: July 21, 2008): Postoperative analgesic consumption in oral oxycodone equivalents [ Time Frame: 3 and 6 months post-operatively ]

Current Secondary Outcome Measures (submitted: April 14, 2017)

• Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents [ Time Frame: From admission to the end of surgery ]
  The cumulative opioid consumption is calculated as fentanyl equivalent
• Time From the End of Surgery to Readiness for Hospital Discharge. [ Time Frame: Until hospital discharge, assessed up to 6 months ]
• Pain Scores on Numerical Rating Scale [ Time Frame: After surgery until the second postoperative mornings. ]
  Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.
• Postoperative Nausea [ Time Frame: After surgery until the second postoperative day. ]
  Number of patients who had postoperative nausea or vomiting were recorded.

Original Secondary Outcome Measures (submitted: July 21, 2008)

• Pre and intraoperative analgesic consumption in fentanyl equivalents [ Time Frame: 3 and 6 months post-operatively ]
• Time from end of surgery to readiness for hospital discharge. [ Time Frame: number of days to hospital discharge ]
• Verbal response pain scores [ Time Frame: PACU admission and discharge,first and second postoperative mornings. ]
• Incidence of postoperative nausea [ Time Frame: Day 1 and day 2 post-operatively ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
• Official Title: The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pain
• Nausea

Intervention

• 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
• 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).
• Other: placebo
  placebo

Study Arms

• Active Comparator: 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
  Intervention: Drug: ropivacaine
• Active Comparator: 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.
  Intervention: Drug: Lidocaine/Ketamine
• Placebo Comparator: Placebo
  General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
  Intervention: Other: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 14, 2017): 12
• Original Estimated Enrollment (submitted: July 21, 2008): 486
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00720330
• Other Study ID Numbers: 08-385
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kenneth Cummings III, MD, MS, The Cleveland Clinic
• Original Responsible Party: Kenneth Cummings, MD, Cleveland Clinic
• Current Study Sponsor: The Cleveland Clinic
• Original Study Sponsor: Outcomes Research Consortium
• Collaborators: Not Provided

Investigators

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

• PRS Account: The Cleveland Clinic
• Verification Date: March 2019