Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
1 other identifier
interventional
30
1 country
2
Brief Summary
Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2022
Shorter than P25 for phase_3
2 active sites
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
Study Start
First participant enrolled
February 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2022
CompletedMarch 14, 2022
March 1, 2022
4 months
March 3, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain scores
Visual Analogue Score is utilized to assess the postoperative pain
36 hours postoperatively
Study Arms (2)
Group B.
ACTIVE COMPARATORgroup B will receive Inj Bupivicain only in Erector Spinae Plane Block.
Group D
ACTIVE COMPARATORgroup D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.
Interventions
In goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given
Eligibility Criteria
You may qualify if:
- age 18-60years ASA I-III Patients undergoing elective thoracotomies
You may not qualify if:
- Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI\>40kg/m2) Psychiatric illness Diabetic Patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sheikh Zayed Medical College/Hospital Rahim Yar Khan
Rahim Yar Khan, Punjab Province, 64200, Pakistan
Sheikh Zayed Medical College/Hospital
Rahim Yar Khan, Punjab Province, 64200, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
amjad siddique, FCPS
Assistant Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 3, 2022
First Posted
March 14, 2022
Study Start
February 15, 2022
Primary Completion
June 15, 2022
Study Completion
July 10, 2022
Last Updated
March 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share