Healing Surgical Wounds Clinical Trial
Official title:
The Effect of Local Wound Infiltration Versus Caudal Block on Wound Infection and Healing After Inguinal Herniotomy Paediatrics
Verified date | December 2018 |
Source | Faculty of Medicine, University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | November 6, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 12 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Faculty of Medicine, University of Alexandria |
Egypt,
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].
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. Review. — View Citation
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. Erratum in: BMJ 1992 Mar 21;304(6829):739. — View Citation
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. — View Citation
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. Review. — View Citation
Eldor J. The antibacterial and antifungal effects of bupivacaine wound analgesia. JNYSORA 2009; 14:1-14.
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. — View Citation
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. Review. — View Citation
Jöhr 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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pain score (Faces) | Faces 0-2 | one day. | |
Secondary | Pain score (Legs) | Legs 0-2 | one day. | |
Secondary | Pain score (Activity) | Activity 0-2 | one day. | |
Secondary | Pain score (Cry) | Cry 0-2 | one day. | |
Secondary | Pain score (Consolability) | Consolability 0-2 | one day. |
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