Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Elective Caesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sequential intrathecal injection of fentanyl and bupivacaine

intrathecal 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

Group Type ACTIVE_COMPARATOR

sequential intrathecal injection

Intervention Type PROCEDURE

intrathecal injection of fentanyl and hyperbaric bupivacaine

hyperbaric bupivacaine

Intervention Type DRUG

intrathecal injection of intrathecal bupivacaine

fentanyl

Intervention Type DRUG

intrathecal injection of fentanyl

rapid sequential intrathecal injection of fentanyl and bupiva

intrathecal 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.

Group Type EXPERIMENTAL

sequential intrathecal injection

Intervention Type PROCEDURE

intrathecal injection of fentanyl and hyperbaric bupivacaine

hyperbaric bupivacaine

Intervention Type DRUG

intrathecal injection of intrathecal bupivacaine

fentanyl

Intervention Type DRUG

intrathecal injection of fentanyl

Interventions

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sequential intrathecal injection

intrathecal injection of fentanyl and hyperbaric bupivacaine

Intervention Type PROCEDURE

hyperbaric bupivacaine

intrathecal injection of intrathecal bupivacaine

Intervention Type DRUG

fentanyl

intrathecal injection of fentanyl

Intervention Type DRUG

Other Intervention Names

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sequential spinal anaesthesia heavy marcaine opioid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No