- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277974
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
March 3, 2022 updated by: Amjad Siddique, Sheikh Zayed Medical College
Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amjad Siddique, FCPS
- Phone Number: 159 0689230165
- Email: dramjadsiddique74@gmail.com
Study Contact Backup
- Name: saira sadaf, FCPS
- Phone Number: 159 0689230165
- Email: sairahbabar@live.com
Study Locations
-
-
Punjab
-
Rahim yar khan, Punjab, Pakistan, 64200
- Recruiting
- Sheikh Zayed Medical College/Hospital Rahim Yar Khan
-
Contact:
- Amjad Siddique, FCPS
- Phone Number: 159 0689230165
- Email: dramjadsiddique74@gmail.com
-
Rahim yar khan, Punjab, Pakistan, 64200
- Recruiting
- Sheikh Zayed Medical college/hospital
-
Contact:
- Amjad Siddique, FCPS
- Phone Number: 159 0689230165
- Email: dramjadsiddique74@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group B.
group B will receive Inj Bupivicain only in Erector Spinae Plane Block.
|
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
Other Names:
|
|
ACTIVE_COMPARATOR: Group D
group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain scores
Time Frame: 36 hours postoperatively
|
Visual Analogue Score is utilized to assess the postoperative pain
|
36 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: amjad siddique, FCPS, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2022
Primary Completion (ANTICIPATED)
June 15, 2022
Study Completion (ANTICIPATED)
July 10, 2022
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (ACTUAL)
March 14, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 14, 2022
Last Update Submitted That Met QC Criteria
March 3, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- ASIDDIQUE SZMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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