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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770013
• Other study ID #: aswu/182/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• bupivacaine
bupivacaine 0.25% a total volume of 40 ml (20 ml each side
• Dexmedetomidine
Dexmedetomidine 0.5 mcg/kg
• clonidine
1ug/kg clonidine
• placebo
add placebo 9normal saline)

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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