Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block
1 other identifier
interventional
24
1 country
1
Brief Summary
TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 postoperative-pain
Started Nov 2017
Typical duration for phase_2 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedStudy Start
First participant enrolled
November 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 22, 2020
October 1, 2020
1.1 years
October 30, 2017
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
measure dexmedetomidine level into systemic circulation after local administration
assessment of systemic dexmedetomidine level after local administration in TAP block after 15 minutes after giving the block, 30 min, 45 min, 1hrs, 2hrs, 4hrs and 6
up to 6 hours
Secondary Outcomes (1)
total dose of IV PCA morphine consumption in the first 24 h postoperative
24 hours
Study Arms (2)
Dexmedetomidine group
ACTIVE COMPARATORpatients were given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine + dexmedetomidine 1 μg•kg-1 diluted in 20 ml saline
bupivacaine group
PLACEBO COMPARATORpatients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine
Interventions
20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1
Eligibility Criteria
You may qualify if:
- ASA I-II
- patients (age 18-60 years
- weight 50-89 kg
You may not qualify if:
- a known allergy to the study drugs
- significant cardiac
- respiratory, renal or hepatic diseases
- bleeding diathesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer instIitute
Asyut, 171516, Egypt
Related Publications (1)
El Sherif FA, Abdel-Ghaffar H, Othman A, Mohamed S, Omran M, Shouman S, Hassan N, Allam A, Hassan S. Pharmacokinetics and Pharmacodynamics of Dexmedetomidine Administered as an Adjunct to Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgery. J Pain Res. 2022 Jan 4;15:1-12. doi: 10.2147/JPR.S335806. eCollection 2022.
PMID: 35035233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia , ICU and pain management
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 1, 2017
Study Start
November 11, 2017
Primary Completion
December 1, 2018
Study Completion
September 1, 2019
Last Updated
October 22, 2020
Record last verified: 2020-10