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

NCT06820203 | Completed

• 1 other identifier: 36264PR1048/1/25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to the 1st rescue analgesia

  Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).

  24 hours postoperatively

Secondary Outcomes (7)

• Total analgesic consumption

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Onset of motor block

  Intraoperatively

• Duration of motor block

  Intraoperatively

• Onset of sensory block

  Intraoperatively

Study Arms (3)

Premixed group

EXPERIMENTAL

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

Drug: Fentanyl and Bupivacaine

Sequential group

EXPERIMENTAL

Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.

Drug: Fentanyl and Bupivacaine

Manual mixed group

ACTIVE COMPARATOR

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

Drug: Fentanyl and Bupivacaine

Interventions

Fentanyl and Bupivacaine DRUG

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

Premixed group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women undergoing cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Fentanyl; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 12, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)