Back to resultsEfficacy Study of Rectus Sheath Block to Control Postoperative Pain (UGRSB)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound guided rectus sheath block
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring laparotomy, levobupivacaine, patient controlled analgesia
Eligibility 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
Sites / Locations
- Department of Anesthesiology, Cukurova University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ultrasound guided rectus sheath block
iv morphine
Arm Description
Ultrasound guided rectus sheath block
0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period
Outcomes
Primary Outcome Measures
Pain Scores on the FLACC scale
FLACC scale has been used to measure postoperative pain level in children
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02115087
Brief Title
Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
Acronym
UGRSB
Official Title
The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
laparotomy, levobupivacaine, patient controlled analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound guided rectus sheath block
Arm Type
Experimental
Arm Description
Ultrasound guided rectus sheath block
Arm Title
iv morphine
Arm Type
Active Comparator
Arm Description
0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided rectus sheath block
Other Intervention Name(s)
US guided rectus sheath block
Intervention Description
the application of rectus sheath block with ultrasound guidance
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Pain Scores on the FLACC scale
Description
FLACC scale has been used to measure postoperative pain level in children
Time Frame
Twenty-four hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Ozcengiz, Prof.
Organizational Affiliation
Department of Anesthesiology, Cukurova University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Cukurova University Faculty of Medicine
City
Adana
ZIP/Postal Code
01130
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
21377070
Citation
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.
Results Reference
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Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
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