Effect of Prilocaine on Motor Block During Caesarean Section

A Randomized Comparative Study on the Effect of Using Intrathecal Hyperbaric Prilocaine Plus Fentanyl Compared to Hyperbaric Bupivacaine Plus Fentanyl on the Motor Block in Women Undergoing Caesarean Section Under Spinal Anesthesia

To compare the effects of using intrathecal prilocaine combined with fentanyl on duration of motor block versus that of intrathecal bupivacaine combined with fentanyl in elective caesarean section.

Study Overview

• Status: Completed
• Conditions: Spinal for Caesarean Section
• Intervention / Treatment: Drug: prilocaine; Drug: bupivacaine

Detailed Description

The participants in this study will be randomized into two groups based on computer generated numbers using online randomization program (research randomizer). Upon arrival to the operating room, patients will be monitored using electrocardiography, pulse oximetry, and non-invasive blood pressure monitor. The baseline values will be recorded .Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 minutes interval during the procedure and during the PACU stay. An 18G-cannulae will be inserted, and pre-medication drugs will be delivered (metoclopramide 10mg). and 4-8 mL/ kg crystalloid infusion will be initiated . Nasal oxygen 3 L / min will be administered during the whole procedure.

• Group P: patients assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
• Group B: patient assigned to this group will receive intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age (18-35)
• ASA II
• Singleton, full term pregnant females.
• Height (1.60-1.90) m.
• BMI > 35 kg m-2
• Scheduled for elective caesarean section under spinal anesthesia.

Exclusion Criteria:

• Patients requiring general anaesthesia
• Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
• Known peripheral neuropathy, neurological deficits or skeletal deformities.
• Known allergy to prilocaine, bupivacaine , fentanyl.
• Infection at site of injection.
• Patients' refusal to sign informed consent
• Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction less than 50%, heart block and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine	Drug: bupivacaine; intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml
Experimental: prilocaine	Drug: prilocaine; intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to motor block	time from intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block) (from3 to 5 minutes).

Secondary Outcome Measures

Outcome Measure	Time Frame
time to sensory block (T4)	time from intrathecal drug injection and complete absence of skin sensation to the pinprick test at T4 (from 1 to 5 minutes)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: caesarean section; prilocaine; spinal enesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Bupivacaine
• Other Study ID Numbers: MS-268-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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