Lidocaine and Ketamine in Abdominal Surgery

NeuroTherapia, Inc.

Status: Terminated

Conditions: Abdominal Hysterectomy (& Wertheim)

Treatments: Drug: Ketamine; Drug: Ketamine + Lidocaine; Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00721110

08-454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

ketamine + Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine + Lidocaine