Expired Study
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Mayfield Heights, Ohio 44124


Purpose:

This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.


Study summary:

Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.


Criteria:

Inclusion Criteria: - Age greater than 18 years old and less than 75 years years old - Horizontal abdominal incision Exclusion Criteria: - Emergency or urgent procedure - Preexisting chronic pain (at any site) requiring treatment - Contraindication to any study medication (ketamine or lidocaine) - 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 - Seizure disorder requiring medication within past 2 years - Planned spinal or epidural anesthesia or analgesia


NCT ID:

NCT00721110


Primary Contact:

Principal Investigator
Martin Grady, MD
Cleveland Clinic/Hillcrest Hospital


Backup Contact:

N/A


Location Contact:

Mayfield Heights, Ohio 44124
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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