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

Postoperative Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863977
• Other study ID #: IRB:17100670
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 15, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.