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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Fentanyl; Bupivacaine; Intrathecal; Premixed; Sequential; Manually Mixed
• Intervention / Treatment: Drug: Fentanyl and Bupivacaine; Drug: Fentanyl and Bupivacaine; Drug: Fentanyl and Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premixed group; Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.	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.
Experimental: Sequential group; Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.	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.
Active Comparator: Manual mixed group; Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic consumption	The total amount of analgesic the patient will be given within 24 h after spinal anesthesia	24 hours postoperatively
Degree of pain	The degree of pain will be assessed using the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24h postoperatively.	24 hours postoperatively
Onset of motor block	onset of motor block (defined as the time from giving spinal anesthesia until a modified Bromage score of 3 was reached). The modified Bromage scale [0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)]	Intraoperatively
Duration of motor block	Duration of motor block (defined as the time from the onset of motor blockade until complete recovery, indicated by a Bromage score of 0) will be recorded	Intraoperatively
Onset of sensory block	Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).	Intraoperatively
Duration of sensory block	Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.	Intraoperatively
Incidence of complications	Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Bupivacaine; Fentanyl
• Other Study ID Numbers: 36264PR1048/1/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No