- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209478
Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients
January 10, 2020 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Pediatric Patients; a Prospective, Randomized, Controlled Study
In the pediatric age group, postoperative pain is very important for the children to have a comfortable and problem-free postoperative period.
In the present study, it was aimed to compare the postoperative analgesic efficacy of Transversus abdominis plane (TAP) Block, and quadratus lumborum block (QLB) Type 1 on the pediatric patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients included in the study were randomly divided into 2 groups.
Cases were assessed ultrasonography-guided TAP block (Group B, n=20) or ultrasonography-guided QL Block.
Total analgesic amounts in 24 hours and first analgesic requirement times recorded.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34000
- Döndü Genç Moralar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with American Society of Anesthesiologist I-II level.
Exclusion Criteria:
- Cases with American Society of Anesthesiologist III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TAP Block
Cases were assessed transversus abdominis plane block for postoperative analgesia
|
The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain).
During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration
Other Names:
|
|
Experimental: QL Block
Cases were assessed quadratus lumborum block for postoperative analgesia
|
The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain).
During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the analgesic use of the groups in 24 hours
Time Frame: how many times in 24 hours
|
the number of analgesic requirements
|
how many times in 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Actual)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 10, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BakirkoySadiKonu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Pain, Postoperative
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of ManitobaUnknown
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Tramadol hydrochloride
-
Federal Teaching Hospital AbakalikiCompletedLabour DurationNigeria
-
Shandong Suncadia Medicine Co., Ltd.RecruitingPostoperative AnalgesiaChina
-
Shandong Suncadia Medicine Co., Ltd.RecruitingPostoperative Pain in OrthopaedicsChina
-
Daewon Pharmaceutical Co., Ltd.CompletedAcute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
-
CrystalGenomics, Inc.Completed
-
Janssen Korea, Ltd., KoreaCompleted
-
Daewon Pharmaceutical Co., Ltd.Completed
-
Janssen Pharmaceutical K.K.Completed
-
Unither Pharmaceuticals, FranceInternational Pharmaceutical Research CenterCompleted