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Efficacy Study of Rectus Sheath Block to Control Postoperative Pain (UGRSB)

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ClinicalTrials.gov Identifier: NCT02115087
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ersel GULEC, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: ultrasound guided rectus sheath block Drug: Morphine Phase 4

Detailed Description:
Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: ultrasound guided rectus sheath block
Ultrasound guided rectus sheath block
Procedure: ultrasound guided rectus sheath block
the application of rectus sheath block with ultrasound guidance
Other Name: US guided rectus sheath block

Active Comparator: iv morphine
0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period
Drug: Morphine



Primary Outcome Measures :
  1. Pain Scores on the FLACC scale [ Time Frame: Twenty-four hours ]
    FLACC scale has been used to measure postoperative pain level in children



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-II
  • 3-15 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

Exclusion Criteria:

  • 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

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): NCT02115087


Locations
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Turkey
Department of Anesthesiology, Cukurova University Faculty of Medicine
Adana, Turkey, 01130
Sponsors and Collaborators
Cukurova University
Investigators
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Principal Investigator: Dilek Ozcengiz, Prof. Department of Anesthesiology, Cukurova University Faculty of Medicine

Publications:
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Responsible Party: Ersel GULEC, Assist.Prof., Cukurova University
ClinicalTrials.gov Identifier: NCT02115087    
Other Study ID Numbers: UGRSB-123
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by Ersel GULEC, Cukurova University:
laparotomy
levobupivacaine
patient controlled analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents