NCT03415087

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

December 24, 2017

Last Update Submit

January 27, 2018

Conditions

Elective Caesarean Section

Outcome Measures

Primary Outcomes (1)

  • Duration of postoperative analgesia

    technique provides prolonged post operative analgesia

    2-5 hours

Secondary Outcomes (1)

  • incidence of hypotension

    30 minutes

Study Arms (2)

sequential intrathecal injection of fentanyl and bupivacaine

ACTIVE COMPARATOR

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

Procedure: sequential intrathecal injectionDrug: hyperbaric bupivacaineDrug: fentanyl

rapid sequential intrathecal injection of fentanyl and bupiva

EXPERIMENTAL

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.

Procedure: sequential intrathecal injectionDrug: hyperbaric bupivacaineDrug: fentanyl

Interventions

sequential intrathecal injectionPROCEDURE

intrathecal injection of fentanyl and hyperbaric bupivacaine

Also known as: sequential spinal anaesthesia
rapid sequential intrathecal injection of fentanyl and bupivasequential intrathecal injection of fentanyl and bupivacaine
hyperbaric bupivacaineDRUG

intrathecal injection of intrathecal bupivacaine

Also known as: heavy marcaine
rapid sequential intrathecal injection of fentanyl and bupivasequential intrathecal injection of fentanyl and bupivacaine
fentanylDRUG

intrathecal injection of fentanyl

Also known as: opioid
rapid sequential intrathecal injection of fentanyl and bupivasequential intrathecal injection of fentanyl and bupivacaine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales undergoing CS
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FentanylAnalgesics, Opioid

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 24, 2017

First Posted

January 30, 2018

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01