NCT04095013

Brief Summary

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 14, 2019

Last Update Submit

September 17, 2019

Conditions

Cesarean Section Complications

Keywords

Elective low segment caesarean sectionIntrathecalbupivacaine-fentanylbupivacaine-dexmedetomidinesensory blockcomplicationshemodynamics

Outcome Measures

Primary Outcomes (8)

  • Time till T10 dermatome achieved (Sec)

    Spinal block characteristics

    Post operative initial hour

  • Time of maximum bromage achieved (Sec)

    Spinal block characteristics

    Post operative initial hour

  • Regression time to T10 dermatome (Min)

    Spinal block characteristics

    Post operative initial hour

  • Time of complete motor recovery (Min)

    Spinal block characteristics

    Post operative initial hour

  • Post-operative pain score

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

    1 hour

  • Post-operative pain score

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

    2 hour

  • Post-operative pain score

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

    3 hour

  • Post-operative pain score

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

    4 hour

Secondary Outcomes (7)

  • Nausea

    24 hours Post operative

  • Vomiting

    24 hours Post operative

  • Pruritus

    24 hours Post operative

  • Respiratory distress

    24 hours Post operative

  • Shivering

    24 hours Post operative

  • +2 more secondary outcomes

Other Outcomes (30)

  • Systolic Blood Pressure

    Baseline

  • Systolic Blood Pressure

    Immediate after giving intrathecal injection and positoning

  • Systolic Blood Pressure

    at 5 minute

  • +27 more other outcomes

Study Arms (2)

Group BF

EXPERIMENTAL

hyperbaric Bupivacaine 10mg with fentanyl 10micrograms

Drug: Bupivacaine, fentanyl

Group BD

EXPERIMENTAL

hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Drug: Bupivacaine, dexmedetomidine

Interventions

Bupivacaine, fentanylDRUG

Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,

Group BF
Bupivacaine, dexmedetomidineDRUG

Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Group BD

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnancy Singleton ASA I and II, BMI \<35, elective C/section

You may not qualify if:

  • patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Civil Hospital Karachi

Karachi, Sindh, 75520, Pakistan

Location

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, 75520, Pakistan

Location

MeSH Terms

Interventions

BupivacaineFentanylDexmedetomidine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Patients were randomly allocated into two groups and will be blinded to the study drugs. The drugs will be chosen by seal envelope method by principal investigator and co-investigator. The drugs will be filled in the syringes and the syringes handed over to on floor consultant anesthetist who are blinded to the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomize controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 19, 2019

Study Start

February 1, 2019

Primary Completion

June 15, 2019

Study Completion

July 15, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)