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NCT Number: NCT06680167

Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section

Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Sohag University Hospitals

Sohag, Sohag Governorate, 82749, Egypt

About this study

Patients will be randomly allocated into two groups:

  • Prilocaine Group (Group A):
  • Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
  • The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
  • The injection will be performed at the L3-L4 or L4-L5 interspace.
  • Bupivacaine Group (Group B):
  • Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
  • The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
  • The injection will be performed at the L3-L4 or L4-L5 interspace.

Procedure Details:

Prior to the procedure, patients will be preloaded with 500 ml of balanced crystalloid solution intravenously. Patients will be positioned in the sitting position for the spinal injection.

The chosen interspace (L3-L4 or L4-L5) will be identified, and the skin will be prepared with an antiseptic solution. A 25 Gauge spinal needle will be used for the intrathecal injection (midline or paramedian technique). After confirming free flow of cerebrospinal fluid, the prepared anesthetic solution will be injected over 10-15 seconds. Following the injection, patients will be placed supine with a slight left lateral tilt to avoid aortocaval compression. The sensory block level will be assessed using Pinprick sensation test, and the motor block will be evaluated using the modified Bromage scale. 5 Blood pressure and heart rate will be monitored every 5 mins until the end of the surgery. In case of hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg), intravenous boluses of 10 mg ephedrine will be administered until blood pressure stabilizes. In case of Bradycardia with Heart rate <55 bpm atropine sulphate 0.01 mg/kg will be given intravenous. Pain Assessment will be done postoperatively via Visual analogue score (VAS) as following if score 3 or less no analgesia required if score 4-5, 1g paracetamol iv will be given if score 6-7, 30mg ketorolac iv will be given if score 7 or more, 2.5mg morphine sulphate iv will be given

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women aged 18-45 years.
  • Patients with uncomplicated pregnancies.
  • American society of anesthesiologist (ASA) physical status I or II.
  • Height between 155 cm and 175 cm.
  • Written informed consent provided. -

Exclusion criteria

  • Patients with known allergies to local anesthetics.
  • Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).
  • Severe preeclampsia or eclampsia.
  • Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).
  • History of spinal surgery or significant spinal deformity.
  • Patients who refuse to participate in the study -

Treatment and study plan

Spinal anesthesia (heavy bupivacaine 0.5%)

Drug

12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section

spinal anesthesia (hyperbaric Prilocaine 2%)

Drug

60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section

Primary outcomes

  1. Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section

    Time frame: 12 HOURS

  2. 2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

A Comparative Study Between Hyperbaric Prilocaine 2% Versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Mar 30, 2026

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.

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