Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355271
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Brief Title:
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
Sponsor:
Ente Ospedaliero Cantonale Bellinzona
Organization:
Ente Ospedaliero Cantonale Bellinzona
Study Overview
Official Title:
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine A Single Center Randomized Multiple Blinded Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoFe
Brief Summary:
Based on randomization patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery
Detailed Description:
In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 05 morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position Sterile saline will be used to dilute the mixture to a final volume of 31 mL The allocated treatment will be kept a secret from the patient the anesthesiologist managing the patient and the entire study team The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patients treatment For 24 hours following surgery each patient would receive intravenous patient-controlled morphine analgesia In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 05 and morphine sulfate 100 mcg The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position Sterile saline will be used to dilute the mixture to a final volume of 31 mL The allocated treatment will be kept a secret from the patient the anesthesiologist managing the patient and the entire study team For 24 hours following surgery each patient would receive intravenous patient- controlled morphine analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None