NCT00721110

Lidocaine and Ketamine in Abdominal Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Hysterectomy (& Wertheim)

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo boluses and infusions will be substituted
DRUG	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.
DRUG	Ketamine + Lidocaine	both Ketamine and Lidocaine will be given

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-10-01
• Completion: 2012-07-01
• First posted: 2008-07-23
• Last updated: 2017-07-26
• Results posted: 2017-07-26

Locations

1 site across 1 country: United States