Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
UGRSB
The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedApril 15, 2014
April 1, 2014
4 months
April 9, 2014
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Scores on the FLACC scale
FLACC scale has been used to measure postoperative pain level in children
Twenty-four hours
Study Arms (2)
ultrasound guided rectus sheath block
EXPERIMENTALUltrasound guided rectus sheath block
iv morphine
ACTIVE COMPARATOR0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period
Interventions
the application of rectus sheath block with ultrasound guidance
Eligibility Criteria
You may qualify if:
- ASA physical status I-II
- years of age children
- Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision
You may not qualify if:
- ASA physical status III and above
- Parents who did not consider to participate in the study
- Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Cukurova University Faculty of Medicine
Adana, 01130, Turkey (Türkiye)
Related Publications (1)
Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.
PMID: 21377070BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dilek Ozcengiz, Prof.
Department of Anesthesiology, Cukurova University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist.Prof.
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 15, 2014
Study Start
September 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
April 15, 2014
Record last verified: 2014-04