Clinical trial NCT00721110: Lidocaine and Ketamine in Abdominal Surgery
Official title: Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Hysterectomy (& Wertheim)
Keywords: pain control
nausea
surgery recovery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
timeFrame: postoperative day 2
Secondary outcomes:
measure: Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
timeFrame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2
measure: Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
timeFrame: intraoperative through postoperative day 2
measure: Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
timeFrame: 2 hours after surgery, on postoperative day 1
measure: Verbal Response Fatigue Score on Postoperative Day 1
timeFrame: postoperative day 1
Other outcomes:
Locations:
city: Mayfield Heights
country: United States
facility: Cleveland Clinic/Hillcrest Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Martin Grady, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: