Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases (ESPPOP)
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|ClinicalTrials.gov Identifier: NCT03790566|
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia and Analgesia Pediatrics Urologic Surgical Procedures||Drug: Bupivacaine||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases|
|Actual Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||September 2, 2019|
|Estimated Study Completion Date :||September 25, 2019|
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
- Remifentanil need [ Time Frame: During the operation ]Intraoperative remifentanil requirement as rescue analgesia
- 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
- 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
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): NCT03790566
|Contact: Pinar Kendigelen, Assoc. Prof.||+email@example.com|
|Contact: Aybike Onur Gonen, MDfirstname.lastname@example.org|
|Istanbul University Cerrahpasa Medical Faculty||Recruiting|
|Istanbul, Please Select, Turkey, 34098|
|Contact: Pinar Kendigelen, Assoc.Prof. +905325868734 email@example.com|
|Contact: Aybike Onur Gonen, MD +905322701086 firstname.lastname@example.org|
|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.|
|Principal Investigator:||Pinar Kendigelen, Assoc. Prof.||Istanbul University Cerrahpasa Medical Faculty|