Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03415087

Enrollment

Registered

2018-01-30

Start date

2016-01-01

Completion date

2016-07-01

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Caesarean Section

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.

Interventions

PROCEDUREsequential intrathecal injection

intrathecal injection of fentanyl and hyperbaric bupivacaine

DRUGhyperbaric bupivacaine

intrathecal injection of intrathecal bupivacaine

DRUGfentanyl

intrathecal injection of fentanyl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Duration of postoperative analgesia	2-5 hours	technique provides prolonged post operative analgesia

Secondary

Measure	Time frame	Description
incidence of hypotension	30 minutes	note if hypotension occurs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026