Lidocaine and Ketamine in Abdominal Surgery

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00721110
• Other study ID #: 08-454
• Status: Terminated
• Phase: N/A
• First received: July 21, 2008
• Last updated: August 18, 2011
• Start date: July 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2011
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Lidocaine
Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
• Ketamine
Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
• Lidocaine and Ketamine
At general anesthetic induction intravenous lidocaine (1.5 mg/kg) will be given. Upon induction of anesthesia, lidocaine 2 mg/kg/hour, to a maximum of 200 mg/hour, will be infused. The lidocaine infusion will be reduced to 1.3 mg/kg/hour up to 133 mg/hour at skin closure and discontinued 24 hours postoperatively. Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.

Other:
• placebo
Placebo boluses and infusions will be substituted for the lidocaine and ketamine not given

Locations

Country	Name	City	State
United States	Cleveland Clinic/Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Before surgery and postoperative day 2	No
Secondary	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	No
Secondary	Total opioid consumption at PACU admission and discharge as well as mornings of postoperative days 1 and 2		postoperative day 2	No
Secondary	Presence or absence of nausea and vomiting after two hours in the PACU and the morning and afternoon of the first postoperative day		2 hours after surgery, morning and afternoon on postoperative day 1	No
Secondary	Verbal response fatigue score on postoperative day 1		postoperative day 1	No
Secondary	10 ml of venous blood will be sampled for cytokine analysis.		2 hours post operatively, 6 and 12 months after surgery	No
Secondary	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)		day 2 postoperatively	No