Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

NCT00720330 | Terminated Results

• 1 other identifier: 08-385
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Nausea

Keywords

Inguinal Herniorrhaphy; Pain assessment; Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents

  From admission to the end of surgery

• 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.

• Postoperative Nausea

  After surgery until the second postoperative day.

Study Arms (3)

Ropivacaine

ACTIVE COMPARATOR

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

Lidocaine/ketamine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

ropivacaine DRUG

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

Ropivacaine

Lidocaine/Ketamine DRUG

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).

Lidocaine/ketamine

placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 and less than 75 years
• Male
• Unilateral inguinal hernia scheduled for elective open repair

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic/Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Pain; Nausea

Interventions

Ropivacaine; Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Roberta Johnson
• Organization: Cleveland Clinic

johnsor13@ccf.org

216-444-9950

Study Officials

• Kenneth Cummings, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 22, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 12, 2019
• Results First Posted: May 19, 2017

Record last verified: 2019-03

Locations

US (1)