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Local Wound Infiltration Versus Caudal Block on Wound Infection and Healing in Paediatrics Inguinal Herniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03563625
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : December 11, 2018
Information provided by (Responsible Party):
Mohammad Hazem I. Ahmad Sabry, University of Alexandria

Brief Summary:
The aim of the present study is to assess effect of local wound infiltration in comparison with caudal block by bupivacaine 0.25% after inguinal herniotomy in pediatrics on: Wound infection and healing (primary outcome) and postoperative analgesia (secondary outcome).

Condition or disease Intervention/treatment Phase
Healing Surgical Wounds Procedure: Caudal block Procedure: Wound infiltration Drug: Bupivacaine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients will be classified randomly into two groups using closed envelope technique, 25 patients each:

Group L: 25 patients will receive 1mg/kg bupivacaine 0.25% (diluted as 1ml bupivacaine + 1ml normal saline) by local infiltration in the wound before closure of the skin and subcutaneous.

Group C: 25 patients will receive caudal block with 1mg/kg bupivacaine 0.25%.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Blinded to procedure done
Primary Purpose: Treatment
Official Title: The Effect of Local Wound Infiltration Versus Caudal Block on Wound Infection and Healing After Inguinal Herniotomy Paediatrics
Actual Study Start Date : November 4, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 6, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: Caudal block
Caudal block with 1mg/kg bupivacaine 0.25%.
Procedure: Caudal block
Caudal block/bupivacaine 0.25%

Drug: Bupivacaine

Active Comparator: Wound infiltration
Local wound infiltration with 1mg/kg bupivacaine 0.25%.
Procedure: Wound infiltration
Local anesthetic wound infiltration/bupivacaine 0.25%

Drug: Bupivacaine

Primary Outcome Measures :
  1. Wound healing will be assessed and will be given grades 0-5 [ Time Frame: 7 days ]
    Wound healing will be assessed and will be given grades 0-5

Secondary Outcome Measures :
  1. Pain score (Faces) [ Time Frame: one day. ]
    Faces 0-2

  2. Pain score (Legs) [ Time Frame: one day. ]
    Legs 0-2

  3. Pain score (Activity) [ Time Frame: one day. ]
    Activity 0-2

  4. Pain score (Cry) [ Time Frame: one day. ]
    Cry 0-2

  5. Pain score (Consolability) [ Time Frame: one day. ]
    Consolability 0-2

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 2 months-1 year
  • Admitted for elective inguinal herniotomy surgery.

Exclusion Criteria:

  • History of developmental delay or mental retardation.
  • Diabetes mellitus type I.
  • Known allergy or contraindication to any local anesthetics.
  • Known congenital anomaly in the inguinal region.
  • Any patient who will develop any infections postoperatively (respiratory infection, urinary infection) other than wound infection will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03563625

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Alexandria Faculty of Medicine
Alexandria, Egypt, 21111
Sponsors and Collaborators
University of Alexandria
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Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD Alexandria Univeristy
Study Director: Ramadan A Ammar, MB,ChB MD Alexandria Univeristy
Principal Investigator: Rana Bakr, MB,ChB Alexandria Univeristy

Eldor J. The antibacterial and antifungal effects of bupivacaine wound analgesia. JNYSORA 2009; 14:1-14.
Anaethesia UK. Pharmacology of regional anaesthesia. Anaethesia UK [Last Updated: 19 Nov, 2009]. Available from: [Accessed on: 16 May, 2016].

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Responsible Party: Mohammad Hazem I. Ahmad Sabry, Lecturer of Anesthesia, University of Alexandria Identifier: NCT03563625     History of Changes
Other Study ID Numbers: 050103846/11-4-2017
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohammad Hazem I. Ahmad Sabry, University of Alexandria:
Local anesthetic
Wound healing

Additional relevant MeSH terms:
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Wound Infection
Surgical Wound
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents