- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291705
Ultrasound-guided Rectus Sheath Block In Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Adana, Turkey, 01130
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rectus sheath block
|
ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine
|
Active Comparator: tramadol
tramadol control group
|
tramadol 1 mg/kg iv
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Scores
Time Frame: postoperative 24 hours
|
postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: dilek ozcengiz, MD, Cukurova University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USG12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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