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

NCT03863977 | Completed Phase 2 DMC

• 1 other identifier: IRB:17100670
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia

Keywords

TAP block; inguinal hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in visual analog scale (VAS)

  2nd, 4th, 8th, 16th, and 24th postoperative hours.

Study Arms (3)

Dex4 group

ACTIVE COMPARATOR

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; Drug: Bupivacaine

Dex8 group

ACTIVE COMPARATOR

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; Drug: Bupivacaine

control group

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

Dexamethasone DRUG

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

Also known as: dexamethasone acetate

Dex4 group; Dex8 group

Bupivacaine DRUG

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

Also known as: plain marcaine

Dex4 group; Dex8 group; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Assiut Governorate, Egypt, 715715, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Dexamethasone; dexamethasone acetate; Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amany Hassan, Lectural

  Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A blinded physician prepared the study medications in color coded syringes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 5, 2019
• Study Start: March 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

EG (1)