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

NCT03563625 | Completed

• 1 other identifier: 050103846/11-4-2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Healing Surgical Wounds

Keywords

Local anesthetic; Hernioraphy; Wound healing

Outcome Measures

Primary Outcomes (1)

• Wound healing will be assessed and will be given grades 0-5

  Wound healing will be assessed and will be given grades 0-5

  7 days

Secondary Outcomes (5)

• Pain score (Faces)

  one day.

• Pain score (Legs)

  one day.

• Pain score (Activity)

  one day.

• Pain score (Cry)

  one day.

• Pain score (Consolability)

  one day.

Study Arms (2)

Caudal block

ACTIVE COMPARATOR

Caudal block with 1mg/kg bupivacaine 0.25%.

Procedure: Caudal block; Drug: Bupivacaine

Wound infiltration

ACTIVE COMPARATOR

Local wound infiltration with 1mg/kg bupivacaine 0.25%.

Procedure: Wound infiltration; Drug: Bupivacaine

Interventions

Caudal block PROCEDURE

Caudal block/bupivacaine 0.25%

Caudal block

Wound infiltration PROCEDURE

Local anesthetic wound infiltration/bupivacaine 0.25%

Wound infiltration

Bupivacaine DRUG

bupivacaine

Caudal block; Wound infiltration

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21111, Egypt

Location

Related Publications (12)

• Eldor J. The antibacterial and antifungal effects of bupivacaine wound analgesia. JNYSORA 2009; 14:1-14.

  BACKGROUND

• Johnson SM, Saint John BE, Dine AP. Local anesthetics as antimicrobial agents: a review. Surg Infect (Larchmt). 2008 Apr;9(2):205-13. doi: 10.1089/sur.2007.036.

  PMID: 18426354 BACKGROUND

• Anaethesia UK. Pharmacology of regional anaesthesia. Anaethesia UK [Last Updated: 19 Nov, 2009]. Available from: http://www.frca.co.uk/article.aspx?articleid=100816. [Accessed on: 16 May, 2016].

  BACKGROUND

• Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.

  PMID: 16682915 BACKGROUND

• Association of Paediatric Anaesthetists of Great Britain and Ireland. Good practice in postoperative and procedural pain management, 2nd edition. Paediatr Anaesth. 2012 Jul;22 Suppl 1:1-79. doi: 10.1111/j.1460-9592.2012.03838.x. No abstract available.

  PMID: 22817132 BACKGROUND

• Fell D, Derrington MC, Taylor E, Wandless JG. Paediatric postoperative analgesia. A comparison between caudal block and wound infiltration of local anaesthetic. Anaesthesia. 1988 Feb;43(2):107-10.

  PMID: 3354802 BACKGROUND

• Lao OB, Fitzgibbons RJ Jr, Cusick RA. Pediatric inguinal hernias, hydroceles, and undescended testicles. Surg Clin North Am. 2012 Jun;92(3):487-504, vii. doi: 10.1016/j.suc.2012.03.017.

  PMID: 22595705 BACKGROUND

• Johr M. Regional anaesthesia in neonates, infants and children: an educational review. Eur J Anaesthesiol. 2015 May;32(5):289-97. doi: 10.1097/EJA.0000000000000239.

  PMID: 25693139 BACKGROUND

• Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.

  PMID: 22696610 BACKGROUND

• Cook TM, Counsell D, Wildsmith JA; Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Br J Anaesth. 2009 Feb;102(2):179-90. doi: 10.1093/bja/aen360. Epub 2009 Jan 12.

  PMID: 19139027 BACKGROUND

• Crellin D, Sullivan TP, Babl FE, O'Sullivan R, Hutchinson A. Analysis of the validation of existing behavioral pain and distress scales for use in the procedural setting. Paediatr Anaesth. 2007 Aug;17(8):720-33. doi: 10.1111/j.1460-9592.2007.02218.x.

  PMID: 17596217 BACKGROUND

• Bailey IS, Karran SE, Toyn K, Brough P, Ranaboldo C, Karran SJ. Community surveillance of complications after hernia surgery. BMJ. 1992 Feb 22;304(6825):469-71. doi: 10.1136/bmj.304.6825.469.

  PMID: 1547415 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohammad Hazem I Ahmad Sabry, MB,ChB MD

  Alexandria Univeristy

  PRINCIPAL INVESTIGATOR

• Ramadan A Ammar, MB,ChB MD

  Alexandria Univeristy

  STUDY DIRECTOR

• Rana Bakr, MB,ChB

  Alexandria Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinded to procedure done
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: 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%.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: June 20, 2018
• Study Start: November 4, 2017
• Primary Completion: October 30, 2018
• Study Completion: November 6, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

EG (1)