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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- time of the first analgesic request
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
A blinded physician prepared the study medications in color coded syringes.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- 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,
Arms & Interventions
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.
Intervention: Dexamethasone (Drug)
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.
Intervention: Bupivacaine (Drug)
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.
Intervention: Dexamethasone (Drug)
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.
Intervention: Bupivacaine (Drug)
control group
After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block.
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
time of the first analgesic request
Time Frame: 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 Outcomes
- change in visual analog scale (VAS)(2nd, 4th, 8th, 16th, and 24th postoperative hours.)
Investigators
Amani Hassan Abdel-Wahab
Principal Investigator
Assiut University