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

NCT ID: NCT03863977

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2020-01-01

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.

Conditions

Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

Bupivacaine

Intervention Type: DRUG

After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

Bupivacaine

Intervention Type: DRUG

After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.

control group

After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.

Interventions

Dexamethasone

After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

Intervention Type: DRUG

Bupivacaine

After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.

Intervention Type: DRUG

Other Intervention Names

dexamethasone acetate; plain marcaine

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amani Hassan Abdel-Wahab

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amany Hassan, Lectural

Role: PRINCIPAL_INVESTIGATOR

Assiut university, Egypt

Locations

Assiut university hospitals

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB:17100670

Identifier Type: -

Identifier Source: org_study_id