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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
Sponsor:
Collaborators:
Aybike Onur Gonen
Ayse Cigdem Tutuncu
Guner Kaya
Rahsan Ozcan
Information provided by (Responsible Party):
pinar kendigelen, Istanbul University

Brief Summary:
Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two common regional anesthesia techniques shown to be effective in open abdominal surgeries. We aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in pediatric open pyeloplasty patients with a flank incision.

Condition or disease Intervention/treatment Phase
Anesthesia and Analgesia Pediatrics Urologic Surgical Procedures Drug: Bupivacaine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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.
Drug: Bupivacaine
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.
Drug: Bupivacaine
0.5 ml/kg 0.25% bupivacaine




Primary Outcome Measures :
  1. Remifentanil need [ Time Frame: During the operation ]
    Intraoperative remifentanil requirement as rescue analgesia

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Pinar Kendigelen, Assoc. Prof. +905325868734 pinarken@gmail.com
Contact: Aybike Onur Gonen, MD +905322701086 aybikeonur@gmail.com

Locations
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Turkey
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Please Select, Turkey, 34098
Contact: Pinar Kendigelen, Assoc.Prof.    +905325868734    pinarken@gmail.com   
Contact: Aybike Onur Gonen, MD    +905322701086    aybikeonur@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.         
Sponsors and Collaborators
Istanbul University
Aybike Onur Gonen
Ayse Cigdem Tutuncu
Guner Kaya
Rahsan Ozcan
Investigators
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Principal Investigator: Pinar Kendigelen, Assoc. Prof. Istanbul University Cerrahpasa Medical Faculty

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Responsible Party: pinar kendigelen, Assoc. Prof., Istanbul University
ClinicalTrials.gov Identifier: NCT03790566     History of Changes
Other Study ID Numbers: 72109855-604.01.01-53213
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by pinar kendigelen, Istanbul University:
ESP block
TAP block
pyeloplasty
erector spina plane block
transversus abdominus plane block
flank incision
post-op analgesia
peri-op analgesia

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents