NCT03770013

Brief Summary

Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

  • Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
  • Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
  • Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

December 6, 2018

Last Update Submit

August 3, 2020

Conditions

Postoperative Pain

Keywords

BupivacaineDexmedetomidineClonidineTransversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • The time for first rescue analgesia after the TAP block

    calculation the time needed for first rescue analgesia after the TAP block

    24 hours post operative

Secondary Outcomes (2)

  • Total dose of rescue analgesia

    24 hours postoperative

  • Adverse effects

    24 hours postoperative

Study Arms (3)

bupivacaine 0.25% and Dexmedetomidine

ACTIVE COMPARATOR

bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)

Drug: bupivacaineDrug: Dexmedetomidine

bupivacaine and clonidine

ACTIVE COMPARATOR

20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP

Drug: bupivacaineDrug: clonidine

bupivacaine and placebo

PLACEBO COMPARATOR

bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP

Drug: bupivacaineDrug: placebo

Interventions

bupivacaineDRUG

bupivacaine 0.25% a total volume of 40 ml (20 ml each side

Also known as: Active Comparator
bupivacaine 0.25% and Dexmedetomidinebupivacaine and clonidinebupivacaine and placebo
DexmedetomidineDRUG

Dexmedetomidine 0.5 mcg/kg

Also known as: Active Comparator
bupivacaine 0.25% and Dexmedetomidine
clonidineDRUG

1ug/kg clonidine

Also known as: Active Comparator
bupivacaine and clonidine
placeboDRUG

add placebo 9normal saline)

Also known as: placebo comparator
bupivacaine and placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients Undergoing Elective Caesarean Section.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • parturients scheduled to undergo cesarean section under spinal anesthesia

You may not qualify if:

  • Patients who refused spinal anesthesia
  • women with chronic pelvic pain or on chronic morphine use
  • history of drug allergy
  • coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineDexmedetomidineClonidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolines

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A prospective Randomized Interventional double-blind study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

August 1, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

EG(1)