Lidocaine and Ketamine in Abdominal Surgery

Not Applicable

Terminated

Interventions: Drug: Ketamine
Drug: Ketamine + Lidocaine
Drug: Placebo
Drug: Lidocaine

Brief Summary: 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
ketamine + Lidocaine	Ketamine + Lidocaine	both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
Placebo	Placebo	A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
Lidocaine	Lidocaine	Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery

Primary Outcome Measures

Name	Time	Method
The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two	postoperative day 2	The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.

Secondary Outcome Measures

Name	Time	Method
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2	PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2	Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2	intraoperative through postoperative day 2
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day	2 hours after surgery, on postoperative day 1
Verbal Response Fatigue Score on Postoperative Day 1	postoperative day 1	Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.