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Ultrasound-guided Rectus Sheath Block In Children

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
rectus sheath block
Tramadol
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Ultrasound, rectus sheath block, children, inguinal hernia

Eligibility Criteria

2 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The children aged 2-7 years scheduled for inguinal hernia repair

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rectus sheath block

tramadol

Arm Description

rectus sheath block

tramadol control group

Outcomes

Primary Outcome Measures

Pain Scores

Secondary Outcome Measures

Full Information

First Posted
November 7, 2014
Last Updated
May 30, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT02291705
Brief Title
Ultrasound-guided Rectus Sheath Block In Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.
Detailed Description
After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated. Primary end point was pain score using FLACC scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Ultrasound, rectus sheath block, children, inguinal hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rectus sheath block
Arm Type
Experimental
Arm Description
rectus sheath block
Arm Title
tramadol
Arm Type
Active Comparator
Arm Description
tramadol control group
Intervention Type
Procedure
Intervention Name(s)
rectus sheath block
Intervention Description
ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
tramadol 1 mg/kg iv
Primary Outcome Measure Information:
Title
Pain Scores
Time Frame
postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The children aged 2-7 years scheduled for inguinal hernia repair Exclusion Criteria: American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dilek ozcengiz, MD
Organizational Affiliation
CUKUROVA UNİVERSİTY
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01130
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24112798
Citation
Breschan C, Jost R, Stettner H, Feigl G, Semmelrock S, Graf G, Likar R. Ultrasound-guided rectus sheath block for pyloromyotomy in infants: a retrospective analysis of a case series. Paediatr Anaesth. 2013 Dec;23(12):1199-204. doi: 10.1111/pan.12267. Epub 2013 Sep 25.
Results Reference
background
PubMed Identifier
24853314
Citation
Flack SH, Martin LD, Walker BJ, Bosenberg AT, Helmers LD, Goldin AB, Haberkern CM. Ultrasound-guided rectus sheath block or wound infiltration in children: a randomized blinded study of analgesia and bupivacaine absorption. Paediatr Anaesth. 2014 Sep;24(9):968-73. doi: 10.1111/pan.12438. Epub 2014 May 22.
Results Reference
background
PubMed Identifier
24348296
Citation
Alsaeed AH, Thallaj A, Khalil N, Almutaq N, Aljazaeri A. Ultrasound-guided rectus sheath block in children with umbilical hernia: Case series. Saudi J Anaesth. 2013 Oct;7(4):432-5. doi: 10.4103/1658-354X.121079.
Results Reference
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Learn more about this trial

Ultrasound-guided Rectus Sheath Block In Children

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