Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-04-24 @ 1:32 AM
Study NCT ID:
NCT02951806
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Sponsor:
Dr. Soliman Fakeeh Hospital
Organization:
Study Overview
Official Title:
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Status:
COMPLETED
Status Verified Date:
2020-09
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:
None
Brief Summary:
Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.
Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.
Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: