- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790566
Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases (ESPPOP)
Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases
Study Overview
Status
Intervention / Treatment
Detailed Description
Regional anesthesia for effective post-operative pain management is a part of the pediatric Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for analgesia for open abdominal surgeries, however difficulties in application and possible complications deter clinicians from utilizing this method. Safe and effective alternatives to epidural anesthesia has been a critical and popular focus of clinical research in recent years. Transversus abdominus plane (TAP) block is an alternative technique shown to be effective in pediatric open abdominal surgeries.
Erector spinae plane (ESP) block was described as an effective block for multi-dermatome pain after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural anesthesia for pelvic, abdominal and thoracic surgery.
During an open pyeloplasty, the flank incision goes through the transversus abdominus plane, where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of erector spinae muscles and the flank incision does not disturb this plane. We aim to compare the effectiveness of ESP block with TAP block in open pyeloplasty patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pinar Kendigelen, Assoc. Prof.
- Phone Number: +905325868734
- Email: pinarken@gmail.com
Study Contact Backup
- Name: Aybike Onur Gonen, MD
- Phone Number: +905322701086
- Email: aybikeonur@gmail.com
Study Locations
-
-
Please Select
-
Istanbul, Please Select, Turkey, 34098
- Recruiting
- Istanbul University Cerrahpasa Medical Faculty
-
Contact:
- Aybike Onur Gonen, MD
- Phone Number: +905322701086
- Email: aybikeonur@gmail.com
-
Contact:
- Pinar Kendigelen, Assoc.Prof.
- Phone Number: +905325868734
- Email: pinarken@gmail.com
-
Principal Investigator:
- Pınar Kendigelen, Assoc.Prof.
-
Sub-Investigator:
- Ayse C Tutuncu, Prof
-
Sub-Investigator:
- Guner Kaya, Prof
-
Sub-Investigator:
- Aybike Onur Gonen, MD
-
Sub-Investigator:
- Rahsan Ozcan, Assoc.Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologist class I, II or III
- Patients scheduled for elective open pyeloplasty surgery
Exclusion Criteria:
- Local anesthetic allergy or other contraindication to local anesthetic use
- Coagulation disorders
- History of chronic pain
- Patient/Family refusal
- History of scoliosis, spinae bifida, abdominal wall defect
- Past surgical procedures with abdominal wall incision
- Plan to extend the flank incision for additional surgical intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erector spinae plane block
With the patient in lateral decubitus position (surgical side up), the transverse processes of T10-T12 vertebrae and erector spinae (ES) fascia are visualized 1-2 cm lateral to the vertebral spine using a linear ultrasound probe.
A 22G peripheral block needle is introduced with in-plane technique under the ES muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.
|
0.5 ml/kg 0.25% bupivacaine
|
Active Comparator: Transversus abdominus plane block
With the patient in supine position, three layers of abdominal muscle are visualized using the linear ultrasound probe held with the long axis on the mid-axillary line above the iliac crest.
22G peripheral block needle is introduced in-plane into the fascia between the internal oblique and transversus abdominus muscles and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.
|
0.5 ml/kg 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remifentanil need
Time Frame: During the operation
|
Intraoperative remifentanil requirement as rescue analgesia
|
During the operation
|
Post-operative analgesia need
Time Frame: 24 hours post-operatively
|
Pain score is assessed with FLACC (Face, Legs, Activity, Cry, Consolability) scale.
A score of 2, 3, 4 or 5 warrants for intravenous paracetamol need and a score of 6 and above warrants for intravenous tramadol
|
24 hours post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental satisfaction with analgesia
Time Frame: 24 hours post-operatively
|
Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied
|
24 hours post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pinar Kendigelen, Assoc. Prof., Istanbul University Cerrahpasa Medical Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 72109855-604.01.01-53213
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.
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