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Completed

NCT Number: NCT03415087

Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed block were recorded.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

56 ASA physical status I, II Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate through a 5ml syringe each (NS (normal sequential), n 28) or a rapid intrathecal injection of fentanyl through an insuline syringe followed by slow injection of hyperbaric bupivacaine through a 5ml syringe RS (rapid sequential), n 28). Onset of sensory block (T6 level), highest level of sensory block, time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain by VAS 6H postoperative, Onset of motor block (Bromage scale0>3), duration of motor block (return to Bromage 0), incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications as nausea, vomiting, pruritis, shivering and failed block were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I, II
  • Parturients aged from 18-40 years old
  • scheduled for elective CS

Exclusion criteria

  • parturients with complicated pregnancy as (preeclampsia, pregnancy induced HTN, gestational Diabetes, abnormal placenta (placenta previa), multiple gestation),
  • BMI greater than 35 or less than 22,
  • major systemic disease (cardiac, renal, liver),
  • need for emergency CS,
  • having allergy to drugs used in the study,
  • having contraindication for spinal anaesthesia or
  • refused regional anaesthesia

Treatment and study plan

sequential intrathecal injection

Procedure

intrathecal injection of fentanyl and hyperbaric bupivacaine

Other names: sequential spinal anaesthesia

Hyperbaric bupivacaine

Drug

intrathecal injection of intrathecal bupivacaine

Other names: heavy marcaine

Fentanyl

Drug

intrathecal injection of fentanyl

Other names: opioid

Primary outcomes

  1. Duration of postoperative analgesia

    Time frame: 2-5 hours

    technique provides prolonged post operative analgesia

Secondary outcomes

  1. incidence of hypotension

    Time frame: 30 minutes

    note if hypotension occurs

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine at Different Rates; Does it Make Difference?

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

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.