Conditions: Abdominal Hysterectomy (& Wertheim)
Keywords: pain control nausea surgery recovery
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 64
Healthy volunteers: no

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.

Arms:
arm 1: Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery arm 2: A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. arm 3: Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery arm 4: both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.

Interventions: intervention 1: Lidocaine intervention 2: Placebo intervention 3: Ketamine intervention 4: Ketamine + Lidocaine
Intervention descriptions: intervention 1: 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. intervention 2: Placebo boluses and infusions will be substituted intervention 3: 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. intervention 4: both Ketamine and Lidocaine will be given

Protocol document: