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

Not Applicable

Recruiting

• Conditions: Premixed; Sequential; Manually Mixed; Intrathecal; Fentanyl; Bupivacaine; Cesarean Section
• Interventions: Drug: Fentanyl and Bupivacaine

• Registration Number: NCT06820203
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Study Start: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premixed group	Fentanyl and Bupivacaine	Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.
Sequential group	Fentanyl and Bupivacaine	Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.
Manual mixed group	Fentanyl and Bupivacaine	Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).

Secondary Outcome Measures

Name	Time	Method
Total analgesic consumption	24 hours postoperatively	The total amount of analgesic the patient will be given within 24 h after spinal anesthesia
Degree of pain	24 hours postoperatively	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.
Onset of motor block	Intraoperatively	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 \[0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)\]
Duration of motor block	Intraoperatively	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
Onset of sensory block	Intraoperatively	Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).
Duration of sensory block	Intraoperatively	Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.
Incidence of complications	24 hours postoperatively	Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt