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Completed

NCT Number: NCT06133881

Effect of Prilocaine on Motor Block During Caesarean Section

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Cairo University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prilocaine

Drug

intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).

Bupivacaine

Drug

intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml

Primary outcomes

  1. time to motor block

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

Secondary outcomes

  1. time to sensory block (T4)

    Time frame: time from intrathecal drug injection and complete absence of skin sensation to the pinprick test at T4 (from 1 to 5 minutes)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.