The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- The Cleveland Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Postoperative Opioid Consumption in Oral Oxycodone Equivalents
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: ropivacaine (Drug)
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: Lidocaine/Ketamine (Drug)
Placebo
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
Intervention: placebo (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents(From admission to the end of surgery)
- Postoperative Nausea(After surgery until the second postoperative day.)
- Time From the End of Surgery to Readiness for Hospital Discharge.(Until hospital discharge, assessed up to 6 months)
- Pain Scores on Numerical Rating Scale(After surgery until the second postoperative mornings.)
Investigators
Kenneth Cummings III, MD, MS
Principal Investigator
The Cleveland Clinic