Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

NCT ID: NCT02620566

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupivacain -Caudal

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

Group Type: ACTIVE_COMPARATOR

Bupivacain- Caudal

Intervention Type: PROCEDURE

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

Bupivacain- Local

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine- Local

Intervention Type: PROCEDURE

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

Interventions

Bupivacain- Caudal

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

Intervention Type: PROCEDURE

Bupivacaine- Local

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

Intervention Type: PROCEDURE

Other Intervention Names

Caudal block; Local Wound Infiltration

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

OTHER

Sponsor Role: lead

Responsible Party

Aleksandra Gavrilovska-Brzanov MD Msc.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandra Gavrilovska-Brzanov, MD. Msc

Role: PRINCIPAL_INVESTIGATOR

Mother Theresa University Clinical Center Skopje Macedonia

Locations

Uctoariced

Skopje, , North Macedonia

Countries

North Macedonia

Other Identifiers

UCTOARICED1

Identifier Type: -

Identifier Source: org_study_id