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

NCT ID: NCT06820203

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2025-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Premixed group

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

Group Type: EXPERIMENTAL

Fentanyl and Bupivacaine

Intervention Type: DRUG

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

Sequential group

Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.

Group Type: EXPERIMENTAL

Fentanyl and Bupivacaine

Intervention Type: DRUG

Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.

Manual mixed group

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

Group Type: ACTIVE_COMPARATOR

Fentanyl and Bupivacaine

Intervention Type: DRUG

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

Interventions

Fentanyl and Bupivacaine

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

Intervention Type: DRUG

Fentanyl and Bupivacaine

Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.

Intervention Type: DRUG

Fentanyl and Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR1048/1/25

Identifier Type: -

Identifier Source: org_study_id