- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969316
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy
The Comparison of Ultrasound-Guided Transversus Abdominis Plane Block and Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy. A Randomized Controlled Trial
Transversus abdominis plane (TAP) and Quadratus lumborum (QL) blocks are used for the management of acute pain treatment, especially after the lower and upper abdominal surgeries.
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.
The investigators' aim in this study, to investigate the effect of the TAP and QL blocks on peroperative and postoperative analgesic consumption in children undergoing unilateral elective orchiopexy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 6 month-12 years old children undergoing unilateral elective orchiopexy with general anesthesia will be recruited, after the informed consent will be obtained from the parents of the patients, in this randomized controlled trial.
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane.
Subsequently, before the surgery, the patients will be randomized and separated into 2 groups. The investigators will apply the QL block to the first group and TAP block to the other group. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both group.
In the peroperative period, if the additional analgesia will necessary, remifentanyl 0.1mcg/kg/min will be started, and dosage will be adjusted according to heart rate and blood pressure. If the blood pressure or heart rate will increase more than 20% from the preoperative basal value will be defined as the need for the analgesia.
In the postoperative period, all cohort will be assessed by a blinded investigator at the 10,20,30th minutes, 1,2nd hours in the recovery room, 6th hour in the surgical ward, Face, Legs, Activity, Cry, Consolability Scale (FLACC) will be used for the pain evaluation. 16th and 24th hours will be monitored by the telephone visit from the parents, the pain will be evaluated with the Wong-Baker Faces Pain Rating Scale due to the same-day surgery concept.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34100
- İstanbul University - Cerrahpaşa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA physical status I-III
- Undergoing elective unilateral orchiopexy
Exclusion Criteria:
- Not giving a consent
- ASA physical status IV
- Need to postoperative ICU care
- History of allergic reactions to anesthetics
- Infection at the injection site
- Laparoscopic Orchiopexy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quadratus Lumborum Block
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room.
After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated.
The maintenance of the anesthesia will be provided with sevoflurane.
0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.
|
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers.
However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.
|
Active Comparator: Transversus Abdominis Plane Block
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room.
After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated.
The maintenance of the anesthesia will be provided with sevoflurane.
0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound between internal oblique and transversus abdominis muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.
|
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers.
However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Analgesia Consumption
Time Frame: 24 hour
|
The required analgesic consumption within the framework of the predetermined protocol will be recorded by the nurses and doctors who do not know which block is used.
After discharge, the family will be called by phone to find out the amount of additional analgesic need.
|
24 hour
|
The Effect on Perioperative and Postoperative Pain
Time Frame: 24 hour
|
The investigator will screen and record perioperative hemodynamic parameters for the perioperative pain evaluation.
The Face, Legs, Activity, Cry, Consobility (FLACC) Score will be used for evaluation of the postoperative pain.
The FLACC pain assessment score is evaluated out of 10 points.
While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively.
If the score is 4 and above, additional analgesic administration will be planned.
|
24 hour
|
The Effect on Post-discharge Pain
Time Frame: 24 hour
|
Post-discharge pain will be assessed by the Wong Baker Score.
Pain will be evaluated based on six facial expressions between zero and ten points.
If the score is four or more, additional analgesic administration will be planned.
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent satisfaction score
Time Frame: 24 hour
|
At the postoperative 24th hour, the investigator will ask to the parents by telephone visit.
Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3)
|
24 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ozgecan P Zanbak, MD, Istanbul University - Cerrahpasa (IUC)
- Study Chair: Ayse C Tutuncu, MD,Prof, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
General Publications
- Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.
- Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
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
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Transversus abdominis plane block, Quadratus lumborum block
-
The General Authority for Teaching Hospitals and...CompletedCesarean Section | Quadratus Lumborum Block | Transversus Abdominis Plane BlockEgypt
-
Uludag UniversityCompleted
-
Muğla Sıtkı Koçman UniversityCompletedProstate Cancer | Nerve Block | Acute Post-operative PainTurkey
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedSurgery | Post Operative Pain | Appendicitis AcuteTurkey
-
Postgraduate Institute of Medical Education and...Completed
-
Eskisehir Osmangazi UniversityRecruitingPostoperative Pain | Inguinal Hernia | Quadratus Lumborum Block | Quality of Recovery | Local Infiltration | Transversus Abdominis Plane BlockTurkey
-
Postgraduate Institute of Medical Education and...UnknownPain Relief to the Patient Following Abdominal SurgeriesIndia
-
Biruni UniversityCompleted
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedPostoperative Complications | Postoperative Pain | Analgesia | Regional Anesthesia MorbidityTurkey
-
Kecioren Education and Training HospitalUnknownPostoperative PainTurkey