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

A

Aswan University Hospital

Status

Completed

Conditions

Postoperative Pain

Treatments

Drug: Dexmedetomidine
Drug: clonidine
Drug: placebo
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03770013
aswu/182/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 3 patient groups, including a placebo group

bupivacaine 0.25% and Dexmedetomidine
Active Comparator group
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.)
Treatment:
Drug: bupivacaine
Drug: Dexmedetomidine
bupivacaine and clonidine
Active Comparator group
Description:
20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
Treatment:
Drug: bupivacaine
Drug: clonidine
bupivacaine and placebo
Placebo Comparator group
Description:
bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
Treatment:
Drug: bupivacaine
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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