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Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

Primary Purpose

Pain, Nausea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ropivacaine
Lidocaine/Ketamine
placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Inguinal Herniorrhaphy, Pain assessment, Outcomes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic/Hillcrest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine

Lidocaine/ketamine

Placebo

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Postoperative Opioid Consumption in Oral Oxycodone Equivalents
The cumulative opioid consumption after surgery until the end of second postoperative day.

Secondary Outcome Measures

Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
The cumulative opioid consumption is calculated as fentanyl equivalent
Time From the End of Surgery to Readiness for Hospital Discharge.
Pain Scores on Numerical Rating Scale
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
Number of patients who had postoperative nausea or vomiting were recorded.

Full Information

First Posted
July 21, 2008
Last Updated
March 8, 2019
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00720330
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment challenges prohibited study progression.
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Nausea
Keywords
Inguinal Herniorrhaphy, Pain assessment, Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Lidocaine/ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Description
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
Intervention Name(s)
Lidocaine/Ketamine
Intervention Description
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
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Postoperative Opioid Consumption in Oral Oxycodone Equivalents
Description
The cumulative opioid consumption after surgery until the end of second postoperative day.
Time Frame
2 days after surgery
Secondary Outcome Measure Information:
Title
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
Description
The cumulative opioid consumption is calculated as fentanyl equivalent
Time Frame
From admission to the end of surgery
Title
Time From the End of Surgery to Readiness for Hospital Discharge.
Time Frame
Until hospital discharge, assessed up to 6 months
Title
Pain Scores on Numerical Rating Scale
Description
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.
Time Frame
After surgery until the second postoperative mornings.
Title
Postoperative Nausea
Description
Number of patients who had postoperative nausea or vomiting were recorded.
Time Frame
After surgery until the second postoperative day.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Cummings, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic/Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

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