MedPath

Finding best practice: use of s-ketamine peroperatively and in patient controlled analgesia in the treatment of pain after major abdominal surgery.

Conditions
Patient between 18 and 70 years old undergoing major abdominal surgery through a midline incision.
Registration Number
EUCTR2008-001700-23-NL
Lead Sponsor
one
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
80
Inclusion Criteria

1.the patient has provided written informed consent prior to admission to the study
2.the patient is between 18 and 70 years of age
3.the patient’s BMI is less than 32

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.the patient has a history of uncontrolled chronic disease which would contraindicate study participation
2.the patient has severe systemic disease that limits activity and is a constant threat to life (ASA IV)
3.the patient has a history of chronic substance abuse within the last 3 months
4.the patient is taking has a history of psychiatric disorders
5.the patient has a history of hypersensitivity to one of the study drugs
6.the patient has a history of severe chronic respiratory disorders
7.the patient is either breastfeeding or pregnant

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary end point(s): 1. The VAS scores per study group.<br>2. The total morphine use over 72 hours.<br>3. The occurence of side effects.;Main Objective: To compare the analgesic potential of all four therapies (VAS Scores)<br>To compare the morphine sparing effect of low-dose ketamine in peroperative infusion and in post operative PCA (Morphine use)<br>To compare the occurence of side effects.<br>;Secondary Objective: To evaluate the effect of the therapies on the levels of amino-acids
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath