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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03770013

Enrollment

150

Registered

2018-12-10

Start date

2019-01-01

Completion date

2020-08-01

Last updated

2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Bupivacaine, Dexmedetomidine, Clonidine, Transversus Abdominis Plane Block

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.

Interventions

DRUGbupivacaine

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

DRUGDexmedetomidine

Dexmedetomidine 0.5 mcg/kg

DRUGclonidine

1ug/kg clonidine

DRUGplacebo

add placebo 9normal saline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blind study.

Intervention model description

A prospective Randomized Interventional double-blind study.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The time for first rescue analgesia after the TAP block	24 hours post operative	calculation the time needed for first rescue analgesia after the TAP block

Secondary

Measure	Time frame	Description
Total dose of rescue analgesia	24 hours postoperative	calculation of Total dose of rescue analgesia required in 24 h post-operatively
Adverse effects	24 hours postoperative	Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026