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Influence of dexamethasone on postoperative analgesia after combined spinal epidural for cesarean delivery.

Conditions
Postoperative pain
Therapeutic 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
NameTimeMethod
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
NameTimeMethod
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)
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