Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

Pain Clinical Trial

Official title:

The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00720330
• Other study ID #: 08-385
• Status: Terminated
• Phase: N/A
• Start date: July 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Nausea
• Pain

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
• 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

Locations

Country	Name	City	State
United States	Cleveland Clinic/Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Consumption in Oral Oxycodone Equivalents	The cumulative opioid consumption after surgery until the end of second postoperative day.	2 days after surgery
Secondary	Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents	The cumulative opioid consumption is calculated as fentanyl equivalent	From admission to the end of surgery
Secondary	Time From the End of Surgery to Readiness for Hospital Discharge.		Until hospital discharge, assessed up to 6 months
Secondary	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.	After surgery until the second postoperative mornings.
Secondary	Postoperative Nausea	Number of patients who had postoperative nausea or vomiting were recorded.	After surgery until the second postoperative day.