Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

Phase 2CompletedNCT02620566

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa80 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

Bupivacain- CaudalPROCEDURE

Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).

Bupivacaine- LocalPROCEDURE

Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Uctoariced

Skopje, North Macedonia

Outcomes

Primary Outcomes

Time to First Analgesic Requirement

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. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative

Time frame: 24 hours

Secondary Outcomes

The total number of oral acetaminophen

Total number of analgesic requirement

Time frame: The number of analgesic received for the period of 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.