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

Tanta University

Status: Completed

Conditions: Cesarean Section; Intrathecal; Fentanyl; Bupivacaine; Sequential; Premixed; Manually Mixed

Treatments: Drug: Fentanyl and Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06820203

36264PR1048/1/25

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 40 years.
• Height between 150 to175 cm.
• Body mass index (BMI) between 18.5 and 30 kg/m2.
• American Society of Anesthesiology (ASA) physical status II.
• Scheduled for cesarean section under spinal anesthesia.

Exclusion criteria

• Pre-operation hypotension and bradycardia.
• Preeclampsia.
• Multiple pregnancy and macrosomia.
• Complete or partial failed spinal.
• Patients with skin infections at the site of injection.
• Patients with coagulation disorders.
• Patients with spinal deformities.
• Patients having regional nerve block other than spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Premixed group

Experimental group

Description:

Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.

Treatment:

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine

Sequential group

Experimental group

Description:

Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.

Treatment:

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine

Manual mixed group

Active Comparator group

Description:

Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.

Treatment:

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine

Drug: Fentanyl and Bupivacaine