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Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia

Sponsor
Sheikh Zayed Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277974
Collaborator
(none)
30
Enrollment
2
Locations
2
Arms
4.8
Anticipated Duration (Months)
15
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: inj bupivicain
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jul 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group B.

group B will receive Inj Bupivicain only in Erector Spinae Plane Block.

Drug: inj bupivicain
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:
  • inj bupivicain plus dexamethasone

    		•
    Active Comparator: Group D

    group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.

    Drug: inj bupivicain
    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:
  • inj bupivicain plus dexamethasone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain scores [36 hours postoperatively]

      Visual Analogue Score is utilized to assess the postoperative pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheikh Zayed Medical College/Hospital Rahim Yar Khan Rahim yar khan Punjab Pakistan 64200
    2 Sheikh Zayed Medical College/Hospital Rahim yar khan Punjab Pakistan 64200

    Sponsors and Collaborators

    • Sheikh Zayed Medical College

    Investigators

    • Principal Investigator: amjad siddique, FCPS, Assistant Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amjad Siddique, Assistant Professor, Sheikh Zayed Medical College
    ClinicalTrials.gov Identifier:
    NCT05277974
    Other Study ID Numbers:
    • ASIDDIQUE SZMC
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amjad Siddique, Assistant Professor, Sheikh Zayed Medical College
    Erector Spinae Plane Block, Thoracotomy, Ultrasound
    Additional relevant MeSH terms:
    Pain, Postoperative
    Dexamethasone

    Study Results

    No Results Posted as of Mar 14, 2022