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
1
3
9.6
9.4

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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2020