Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

NCT02620566 | Completed Phase 1 DMC

• 1 other identifier: UCTOARICED1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia

Keywords

caudal block; local wound infiltration; hernia repair

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (1)

• The total number of oral acetaminophen

  The number of analgesic received for the period of 24 hours

Other Outcomes (2)

• Postoperative Pain

  30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative

• Motor block

  30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative

Study Arms (2)

Bupivacain -Caudal

ACTIVE COMPARATOR

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

Procedure: Bupivacain- Caudal

Bupivacain- Local

ACTIVE COMPARATOR

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

Procedure: Bupivacaine- Local

Interventions

Bupivacain- Caudal PROCEDURE

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

Also known as: Caudal block

Bupivacain -Caudal

Bupivacaine- Local PROCEDURE

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

Also known as: Local Wound Infiltration

Bupivacain- Local

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa: lead

Study Sites (1)

Uctoariced

Skopje, 1000, North Macedonia

Location

Study Officials

• Aleksandra Gavrilovska-Brzanov, MD. Msc

  Mother Theresa University Clinical Center Skopje Macedonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: December 3, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

NO (1)