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NCT Number: NCT03863977

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

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

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Key information

Conditions

Postoperative Analgesia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Assiut Governorate, Egypt, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Dexamethasone

Drug

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

Other names: dexamethasone acetate

Bupivacaine

Drug

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

Other names: plain marcaine

Primary outcomes

  1. 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

  1. change in visual analog scale (VAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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