Back to resultsBupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
inj bupivicain
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Erector Spinae Plane Block, Thoracotomy, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- age 18-60years ASA I-III Patients undergoing elective thoracotomies
Exclusion Criteria:
- 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.
Sites / Locations
- Sheikh Zayed Medical College/Hospital Rahim Yar KhanRecruiting
- Sheikh Zayed Medical College/HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group B.
Group D
Arm Description
group B will receive Inj Bupivicain only in Erector Spinae Plane Block.
group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.
Outcomes
Primary Outcome Measures
postoperative pain scores
Visual Analogue Score is utilized to assess the postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT05277974
First Posted
March 3, 2022
Last Updated
March 3, 2022
Sponsor
Sheikh Zayed Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05277974
Brief Title
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
Official Title
Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
July 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheikh Zayed Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Erector Spinae Plane Block, Thoracotomy, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B.
Arm Type
Active Comparator
Arm Description
group B will receive Inj Bupivicain only in Erector Spinae Plane Block.
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.
Intervention Type
Drug
Intervention Name(s)
inj bupivicain
Other Intervention Name(s)
inj bupivicain plus dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative pain scores
Description
Visual Analogue Score is utilized to assess the postoperative pain
Time Frame
36 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-60years ASA I-III Patients undergoing elective thoracotomies
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amjad siddique, FCPS
Phone
0689230165
Ext
159
Email
dramjadsiddique74@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
saira sadaf, FCPS
Phone
0689230165
Ext
159
Email
sairahbabar@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amjad siddique, FCPS
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheikh Zayed Medical College/Hospital Rahim Yar Khan
City
Rahim yar khan
State/Province
Punjab
ZIP/Postal Code
64200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amjad siddique, FCPS
Phone
0689230165
Ext
159
Email
dramjadsiddique74@gmail.com
Facility Name
Sheikh Zayed Medical College/Hospital
City
Rahim yar khan
State/Province
Punjab
ZIP/Postal Code
64200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amjad Siddique, FCPS
Phone
0689230165
Ext
159
Email
dramjadsiddique74@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
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