Influence of dexamethasone on postoperative analgesia after combined spinal epidural for cesarean delivery.
- Conditions
- Postoperative painTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-001349-41-BE
- Lead Sponsor
- AZ Groeninge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Age>18
Elective cesarean section
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
age<18 years, preterm gestation (<37w), multiple gestations, contraindications for neuraxial anesthesia, intolerance to any of the study drugs, chronic steroid use, chronic opioid use and diabetes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the administration of epidural or intravenous dexamethasone beneficial for postoperative analgesia after cesarean section.;Secondary Objective: Is the administration of epidural or intravenous dexamethasone benificial in the development of postoperative nausea and vomiting after cesarean section.<br><br>Does the administration of epidural or intravenous dexamethasone prevents the development of chronic pain after cesarean section. ;Primary end point(s): Postoperative Analgesic need;Timepoint(s) of evaluation of this end point: 48 hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pain scores (Visual analogue score)<br>Postoperative nausea and vomiting score<br>Development of chronic pain;Timepoint(s) of evaluation of this end point: 48 hours (pain scores/nausea and vomiting)<br>6months/ 1 year (develoment of chronic pain)