Intravenous S-Ketamine as an Analgesic Adjunct to General Anesthesia in chronic opioid-tolerant patient

Conditions: In the present investigation, we will compare the perioperative subanesthetic infusion of ketamine with placebo in opioid-resistant patients undergoing major orthopedic surgery. By powering the study to detect possible differences in the most relevant outcomes, we aim at clarifying whether ketamine should be admistered routinely in this clinical setting.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-004733-14-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients receiving opioid therapy at least three months due to chronic pain or as a drug substitution, acutely undergoing major elective orthopedic surgery will be studied. Written informed consent will be obtained by all patients, on a form entitled Patient information and declaration of consent” (Patienteninformation und Einverständniserklärung) before inclusion into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

opioid therapy < 3 months, any contraindication to ketamine or morphine, age < 18 yr, pregnancy or nursing, intake of psychotropic drugs, significant neurological or psychiatric disorders unrelated to the chronic pain, other severe pain that might impair the assessment of the surgical pain and lack of patient’s cooperation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In the present investigation, we will compare the perioperative subanesthetic infusion of ketamine with placebo in opioid-resistant patients undergoing major orthopedic surgery. ;Secondary Objective: n.a.;Primary end point(s): Pain intensity;Timepoint(s) of evaluation of this end point: hospitalisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): side effects, additional drugs used to treat pain and side effects, duration of Patient Controlled Analgesia (PCA) use. <br>1.Time to first mobilization, quality of mobilization using actigraphy, <br>2.Sleep quality: Actigraphic parameters sleep latency, sleep efficiency, total sleep time during observed pain therapy period.<br>3.Circadian rhythm: Actigraphic parameters amplitude and peak of the circadian rhythm, intra-daily stability/variability during observed pain therapy period.<br>4.Treatment costs, hospital length of stay. <br>5.Number of patients with reduction of chronic pain therapy 3 and 6 months ;Timepoint(s) of evaluation of this end point: hospitalisation