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Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Not Applicable
Completed
Conditions
Elective Caesarean Section
Interventions
Procedure: sequential intrathecal injection
Registration Number
NCT03415087
Lead Sponsor
Ain Shams University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
56
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sequential intrathecal injection of fentanyl and bupivacainehyperbaric bupivacaineintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
sequential intrathecal injection of fentanyl and bupivacainesequential intrathecal injectionintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
rapid sequential intrathecal injection of fentanyl and bupivasequential intrathecal injectionintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
rapid sequential intrathecal injection of fentanyl and bupivahyperbaric bupivacaineintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
sequential intrathecal injection of fentanyl and bupivacainefentanylintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
rapid sequential intrathecal injection of fentanyl and bupivafentanylintrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
Primary Outcome Measures
NameTimeMethod
Duration of postoperative analgesia2-5 hours

technique provides prolonged post operative analgesia

Secondary Outcome Measures
NameTimeMethod
incidence of hypotension30 minutes

note if hypotension occurs

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