Clinical trial NCT02620566: Caudal Block vs Local Wound Infiltration for Hernia Repair in Children
Official title: Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anesthesia
Keywords: caudal block
local wound infiltration
hernia repair
Lead sponsor: University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

Detailed description: Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).

Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.

Eligibility criteria: Inclusion Criteria:

* 6 month to 7 years
* ASA physical status I or II
* undergoing unilateral hernia repair

Exclusion Criteria:

* history of developmental delay or mental retardation
* type I diabetes
* known or suspected coagulopathy
* known allergy to any local anesthetic
* known congenital anomaly of the spine
* signs of spinal anomaly or infection at the sacral or inguinal region

Primary outcomes:
measure: Time to First Analgesic Requirement
timeFrame: 24 hours
Secondary outcomes:
measure: The total number of oral acetaminophen
timeFrame: The number of analgesic received for the period of 24 hours
Other outcomes:
measure: Postoperative Pain
timeFrame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative
measure: Motor block
timeFrame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Uctoariced
Study officials:
affiliation: Mother Theresa University Clinical Center Skopje Macedonia
name: Aleksandra Gavrilovska-Brzanov, MD. Msc
role: PRINCIPAL_INVESTIGATOR
References: