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Ultrasound-guided Rectus Sheath Block In Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291705
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
mediha turktan, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: rectus sheath block Drug: Tramadol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: rectus sheath block
rectus sheath block
Procedure: rectus sheath block
ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine

Active Comparator: tramadol
tramadol control group
Drug: Tramadol
tramadol 1 mg/kg iv




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: postoperative 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291705


Locations
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Turkey
Cukurova University
Adana, Turkey, 01130
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: dilek ozcengiz, MD CUKUROVA UNİVERSİTY
Publications:
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Responsible Party: mediha turktan, assistant Professor, Cukurova University
ClinicalTrials.gov Identifier: NCT02291705    
Other Study ID Numbers: USG12
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Keywords provided by mediha turktan, Cukurova University:
Ultrasound, rectus sheath block, children, inguinal hernia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents