Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain
1 other identifier
interventional
60
1 country
1
Brief Summary
Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
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
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2024
CompletedFebruary 20, 2024
February 1, 2024
11 months
May 1, 2023
February 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Total postoperative morphine consumption
Total dose of morphine needed postoperatively in the first 24 h
First 24 hours postoperatively
Secondary Outcomes (1)
Time to first postoperative rescue analgesia.
First 24 hours postoperatively
Study Arms (3)
Erector spinae plane block with 0.25% bupivacaine
ACTIVE COMPARATORPatients will receive ultrasound guided ESPB with 0.25% bupivacaine
Erector spinae plane block with 0.25% bupivacaine and Magnesium
EXPERIMENTALPatients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium
Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine
EXPERIMENTALPatients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine
Interventions
Bupivacaine 0.25% + Magnesium
Bupivacaine 0.25% + Dexmedetomidine
Eligibility Criteria
You may qualify if:
- Age from 18 to 65 years.
- Male and female sexes.
- ASA I-II.,III
- Cancer patients undergoing thoracotomy incisions
- Body mass index (BMI) from 18.5 to 30 kg/m2
You may not qualify if:
- Patient refusal
- Known allergy to any of the used drugs
- Low platelet count, any coagulation defect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walaa Y Elsabeeny
Cairo, 11796, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walaa Y Elsabeeny, MD
Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
- STUDY DIRECTOR
Ahmed A Mohamed, MD
Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of Anesthesia and Pain management
Study Record Dates
First Submitted
May 1, 2023
First Posted
May 10, 2023
Study Start
May 15, 2023
Primary Completion
March 25, 2024
Study Completion
April 27, 2024
Last Updated
February 20, 2024
Record last verified: 2024-02