search
Back to results

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

Primary Purpose

Anesthesia

Status
Completed
Phase
Phase 1
Locations
Macedonia, The Former Yugoslav Republic of
Study Type
Interventional
Intervention
Bupivacain- Caudal
Bupivacaine- Local
Sponsored by
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring caudal block, local wound infiltration, hernia repair

Eligibility Criteria

6 Months - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Uctoariced

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacain -Caudal

Bupivacain- Local

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The total number of oral acetaminophen
Total number of analgesic requirement

Full Information

First Posted
September 20, 2015
Last Updated
January 3, 2016
Sponsor
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
search

1. Study Identification

Unique Protocol Identification Number
NCT02620566
Brief Title
Caudal Block vs Local Wound Infiltration for Hernia Repair in Children
Acronym
CBvsLWI
Official Title
Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
Keywords
caudal block, local wound infiltration, hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacain -Caudal
Arm Type
Active Comparator
Arm Description
Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%.
Arm Title
Bupivacain- Local
Arm Type
Active Comparator
Arm Description
Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%.
Intervention Type
Procedure
Intervention Name(s)
Bupivacain- Caudal
Other Intervention Name(s)
Caudal block
Intervention Description
Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
Intervention Type
Procedure
Intervention Name(s)
Bupivacaine- Local
Other Intervention Name(s)
Local Wound Infiltration
Intervention Description
Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
Primary Outcome Measure Information:
Title
Time to First Analgesic Requirement
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The total number of oral acetaminophen
Description
Total number of analgesic requirement
Time Frame
The number of analgesic received for the period of 24 hours
Other Pre-specified Outcome Measures:
Title
Postoperative Pain
Description
Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10).
Time Frame
30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative
Title
Motor block
Description
Motor function was assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs.
Time Frame
30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Gavrilovska-Brzanov, MD. Msc
Organizational Affiliation
Mother Theresa University Clinical Center Skopje Macedonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uctoariced
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of

12. IPD Sharing Statement

Learn more about this trial

Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

We'll reach out to this number within 24 hrs