Skip to main content
OpenTrials
Completed

NCT Number: NCT02620566

Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Uctoariced

Skopje, 1000, North Macedonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain- Caudal

Procedure

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

Other names: Caudal block

Bupivacaine- Local

Procedure

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

Other names: Local Wound Infiltration

Primary outcomes

  1. Time to First Analgesic Requirement

    Time frame: 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 outcomes

  1. The total number of oral acetaminophen

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

    Total number of analgesic requirement

Other outcomes

  1. Postoperative Pain

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

    Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10).

  2. Motor block

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

    Motor function was assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs.

Sponsors and collaborators

Lead sponsor

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

Other

Registry information

Official study title

Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration

Acronym: CBvsLWI

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2015
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.