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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Postoperative Analgesia

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 alone
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dex4 group<br>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<br>* After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.<br>* Other names: dexamethasone acetate;Drug: Bupivacaine<br>* After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.<br>* Other names: plain marcaine;|
| Active Comparator: Dex8 group<br>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<br>* After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.<br>* Other names: dexamethasone acetate;Drug: Bupivacaine<br>* After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.<br>* Other names: plain marcaine;|
| Active Comparator: control group<br>After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block. | Drug: Bupivacaine<br>* After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.<br>* Other names: plain marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of the first analgesic request | 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 | in the first postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual analog scale (VAS) | measuring the change in visual analog scale VAS (0: no pain to 10: worst imaginable pain), to evaluate postoperative analgesia | 2nd, 4th, 8th, 16th, and 24th postoperative hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block, inguinal hernia