EUCTR2017-004797-33-BE
Active, not recruiting
Phase 1
The efficacy of continuous ropivacaine wound infusion after cesarean delivery in pain management.
CHU Tivoli0 sites68 target enrollmentApril 4, 2018
ConditionsPoor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Poor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials.
- Sponsor
- CHU Tivoli
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria will be all patients undergoing cesarean delivery with
- •\- a gestation of 34 weeks or more
- •\- American Society of Anesthesiology (ASA) I or II
- •\- \= age 18 years
- •\- signed informed consent
- •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 68
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Exclusion criteria will be
- •\- allergies to used analgesics
- •\- ASA III or higher
- •\- pre\- or eclampsia
- •\- diabetes mellitus type I or II
- •\- postpartum hemorrhage (defined as \= 1 L blood loss)
- •\- BMI \= 35
- •\- preoperative opioid consumption/abuse
- •\- psychiatric disorders
- •\- patient refusal to participate
Outcomes
Primary Outcomes
Not specified
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