Lidocaine and Ketamine in Abdominal Surgery

Condition(s) targeted: Hysterectomy

Intervention: Lidocaine (Drug); Ketamine (Drug); Lidocaine and Ketamine (Drug); placebo (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Outcomes Research Consortium

Official(s) and/or principal investigator(s):
Martin Grady, MD, Principal Investigator, Affiliation: Cleveland Clinic/Hillcrest Hospital
Daniel I Sessler, MD, Study Chair, Affiliation: The Cleveland Clinic
Ivan Parra Sanchez, MD, Study Director, Affiliation: The Cleveland Clinic

Overall contact:
Martin Grady, MD, Phone: 440-312-5259, Email: gradym1@ccf.org

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.

Official title: Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The effects of lidocaine (versus placebo) and ketamine (versus placebo) on functional recovery assessed by 6 minute walk test at baseline and on postoperative day two

Secondary outcome:

Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2

Total opioid consumption at PACU admission and discharge as well as mornings of postoperative days 1 and 2

Presence or absence of nausea and vomiting after two hours in the PACU and the morning and afternoon of the first postoperative day

Verbal response fatigue score on postoperative day 1

10 ml of venous blood will be sampled for cytokine analysis.

The patient is observed and timed rising from a chair with armrests and a seating height of 44-47cm, walking 3 meters, turning around, walking back to the chair and sitting down again. (TUG test)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age greater than 18 and less than 75 years

- Horizontal abdominal incision

Exclusion Criteria:

- Emergency or urgent procedure

- Pre-existing 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

Martin Grady, MD, Phone: 440-312-5259, Email: gradym1@ccf.org

Cleveland Clinic/Hillcrest Hospital, Mayfield Heights, Ohio 44124, United States; Recruiting
Martin Grady, MD, Phone: 440-312-5259, Email: gradym2@accf.org
Rosann Pecharka, RN, Phone: 440-312-7066, Email: pecharr@ccf.org

Starting date: July 2008
Last updated: August 11, 2010