Lidocaine and Ketamine in Abdominal Surgery

NCT00721110 | Terminated Results

• 1 other identifier: 08-454
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Hysterectomy (& Wertheim)

Keywords

pain control; nausea; surgery recovery

Outcome Measures

Primary Outcomes (1)

• The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two

  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.

  postoperative day 2

Secondary Outcomes (4)

• 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

• 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

Study Arms (4)

Lidocaine

ACTIVE COMPARATOR

Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.

Drug: Placebo

Ketamine

ACTIVE COMPARATOR

Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery

Drug: Ketamine

ketamine + Lidocaine

ACTIVE COMPARATOR

both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.

Drug: Ketamine + Lidocaine

Interventions

Lidocaine DRUG

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.

Lidocaine

Placebo DRUG

Placebo boluses and infusions will be substituted

Placebo

Ketamine DRUG

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.

Ketamine

Ketamine + Lidocaine DRUG

both Ketamine and Lidocaine will be given

ketamine + Lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years old and less than 75 years years old
• Horizontal abdominal incision

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic/Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Agnosia; Nausea

Interventions

Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland Clinic

sesslerd@ccf.org

216-444-4200

Study Officials

• Martin Grady, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2012
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)