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Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03863977
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
9.6
Actual Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

The transverses abdominis plane block (TAP block) is a regional anesthesia technique that provides analgesia following abdominal surgery . The TAP block significantly reduces pain after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia technique or as a complement to general anesthesia, spinal or local anesthesia .

The investigators designed this study to compare the postoperative analgesic effect of two doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A blinded physician prepared the study medications in color coded syringes.
Primary Purpose:
Prevention
Official Title:
Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair
Actual Study Start Date :
Mar 15, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dex4 group

After the surgery, the patients in this group will receive 4 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

Drug: Dexamethasone
After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.
Other Names:
  • dexamethasone acetate

    • Drug: Bupivacaine
    After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
    Other Names:
  • plain marcaine

    		•
    Active Comparator: Dex8 group

    After the surgery, the patients in this group will receive 8 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

    Drug: Dexamethasone
    After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.
    Other Names:
  • dexamethasone acetate

    • Drug: Bupivacaine
    After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
    Other Names:
  • plain marcaine

    		•
    Active Comparator: control group

    After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block.

    Drug: Bupivacaine
    After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
    Other Names:
  • plain marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time of the first analgesic request [in the first postoperative 24 hours]

      time of the first analgesic request in the first postoperative 24 hours ,patients will receive analgesia if visual analog scale (VAS) score more than 3

    Secondary Outcome Measures

    1. change in visual analog scale (VAS) [2nd, 4th, 8th, 16th, and 24th postoperative hours.]

      measuring the change in visual analog scale VAS (0: no pain to 10: worst imaginable pain), to evaluate postoperative analgesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients' age from 18 to 60 years old,

    • physical status ASA I-II (by the American Society of Anesthesiologists),

    • Elective unilateral open inguinal hernia repair,

    • Under spinal anesthesia

    Exclusion Criteria:

    • age < 18 or > 60,

    • American society of anesthesiologist (ASA)class III-IV,

    • known allergy to amino amide local anesthetics,

    • skin infection and diseases at site of injection.

    • coagulation disorders,

    • patients with body mass index (BMI) > 35 kg/m2,

    • scrotal hernias,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospitals Assiut Assiut Governorate Egypt Egypt, 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Amany Hassan, Lectural, Assiut university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amani Hassan Abdel-Wahab, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03863977
    Other Study ID Numbers:
    • IRB:17100670
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Amani Hassan Abdel-Wahab, Principal Investigator, Assiut University
    TAP block
    inguinal hernia
    Additional relevant MeSH terms:
    Dexamethasone
    Dexamethasone acetate
    Bupivacaine
    BB 1101

    Study Results

    No Results Posted as of Apr 28, 2020