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| Name | Class |
|---|---|
| Cairo University | OTHER |
| Alexandria University | OTHER |
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Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.
We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-controlled remifentanil analgesia | Active Comparator | Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery |
|
| Epidural analgesia | Placebo Comparator | Patients will received continuous epidural analgesia starting from labour pain until delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-controlled remifentanil analgesia | Drug | Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient's satisfaction | As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied) | For 24 hours after labour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Score at rest | As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain) | For 24 hours after the start of labour pain |
| Pain Visual Analog Score on movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil A Abd El Raouf, MD | Professor in Cardiothoracic Ananesthesia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals | Al Mansurah | DK | 050 | Egypt |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Epidural analgesia | Drug | Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr |
|
As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
| For 24 hours after the start of labour pain |
| Maternal nausea and vomiting | (0: no nausea or vomiting, 1: severe nausea, 3: vomiting) | For 24 hours after the start of labour pain |
| Maternal respiratory depression | If respiratory rate decreases less than 10/min | For 24 hours after the start of labour pain |
| Neonatal Apgar score at 1 min | Assessed using 5-points Apgar score | For 5 min after birth |
| Neonatal Apgar score at 5 min | Assessed using 5-points Apgar score | For 5 min after birth |
| Neonatal blood PaO2 | PaO2 value | For 5 min after birth |
| Neonatal blood PaCO2 | PaCO2 value | For 5 min after birth |
| Neonatal blood pH | pH value | For 5 min after birth |