Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

Phase 1

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Bupivacaine- Local; Procedure: Bupivacain- Caudal

• Registration Number: NCT02620566
• Lead Sponsor: University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Posted: 2015-12-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacain- Local	Bupivacaine- Local	Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%.
Bupivacain -Caudal	Bupivacain- Caudal	Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%.

Primary Outcome Measures

Name	Time	Method
Time to First Analgesic Requirement	24 hours	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

Secondary Outcome Measures

Name	Time	Method
The total number of oral acetaminophen	The number of analgesic received for the period of 24 hours	Total number of analgesic requirement

Trial Locations

Locations (1)

Uctoariced; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of