Caudal Block vs Local Wound Infiltration for Hernia Repair in Children (CBvsLWI)

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

Status and phase: Completed; Phase 2; Phase 1

Conditions: Anesthesia

Treatments: Procedure: Bupivacaine- Local; Procedure: Bupivacain- Caudal

Study type: Interventional

Funder types: Other

Identifiers

NCT02620566

UCTOARICED1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Bupivacain -Caudal

Active Comparator group

Description:

Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%.

Treatment:

Procedure: Bupivacain- Caudal

Bupivacain- Local

Active Comparator group

Description:

Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%.

Treatment:

Procedure: Bupivacaine- Local