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Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

bupivacaine

Dexmedetomidine

clonidine

placebo

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Bupivacaine, Dexmedetomidine, Clonidine, Transversus Abdominis Plane Block

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

parturients scheduled to undergo cesarean section under spinal anesthesia

Exclusion Criteria:

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

Sites / Locations

Aswan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bupivacaine 0.25% and Dexmedetomidine

bupivacaine and clonidine

bupivacaine and placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The time for first rescue analgesia after the TAP block

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

Secondary Outcome Measures

Total dose of rescue analgesia

calculation of Total dose of rescue analgesia required in 24 h post-operatively

Adverse effects

Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.

Full Information

NCT ID

NCT03770013

First Posted

December 6, 2018

Last Updated

August 3, 2020

Sponsor

Aswan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03770013

Brief Title

Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Official Title

Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Bupivacaine, Dexmedetomidine, Clonidine, Transversus Abdominis Plane Block

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective Randomized Interventional double-blind study.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-blind study.

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bupivacaine 0.25% and Dexmedetomidine

Arm Type

Active Comparator

Arm Description

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

Arm Title

bupivacaine and clonidine

Arm Type

Active Comparator

Arm Description

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

Arm Title

bupivacaine and placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

bupivacaine

Other Intervention Name(s)

Active Comparator

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Active Comparator

Intervention Description

Dexmedetomidine 0.5 mcg/kg

Intervention Type

Drug

Intervention Name(s)

clonidine

Other Intervention Name(s)

Active Comparator

Intervention Description

1ug/kg clonidine

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

placebo comparator

Intervention Description

add placebo 9normal saline)

Primary Outcome Measure Information:

Title

The time for first rescue analgesia after the TAP block

Description

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

Time Frame

24 hours post operative

Secondary Outcome Measure Information:

Title

Total dose of rescue analgesia

Description

calculation of Total dose of rescue analgesia required in 24 h post-operatively

Time Frame

24 hours postoperative

Title

Adverse effects

Description

Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.

Time Frame

24 hours postoperative

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Patients Undergoing Elective Caesarean Section.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: parturients scheduled to undergo cesarean section under spinal anesthesia Exclusion Criteria: Patients who refused spinal anesthesia women with chronic pelvic pain or on chronic morphine use history of drug allergy coagulation disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hany f sallam, md

Organizational Affiliation

Aswan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aswan University

City

Aswan

ZIP/Postal Code

81528

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

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