NCT06820203

Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section

Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.

Detailed description

Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia. Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs. Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.

Conditions

• Premixed
• Sequential
• Manually Mixed
• Intrathecal
• Fentanyl
• Bupivacaine
• Cesarean Section

Interventions

Type	Name	Description
DRUG	Fentanyl and Bupivacaine	Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.
DRUG	Fentanyl and Bupivacaine	Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.
DRUG	Fentanyl and Bupivacaine	Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2025-02-11
• Last updated: 2025-07-25

Locations

1 site across 1 country: Egypt