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

Phase 2

Completed

• Conditions: Postoperative Analgesia
• Interventions: Drug: Dexamethasone; Drug: Bupivacaine

• Registration Number: NCT03863977
• Lead Sponsor: Assiut University

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 Timeline

• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Study Start: 2019-03-15
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex4 group	Dexamethasone	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.
Dex4 group	Bupivacaine	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.
Dex8 group	Dexamethasone	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.
Dex8 group	Bupivacaine	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.
control group	Bupivacaine	After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Assiut Governorate, Egypt