CClinicalTrials.gg
Status unknownNCT03790566ESPPOPUpdated Feb 26, 2019

Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases

An interventional study of Bupivacaine in Anesthesia and Analgesia, Pediatrics and Urologic Surgical Procedures, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Istanbul University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia and Analgesia
  • Pediatrics
  • Urologic Surgical Procedures

Keywords

  • ESP block
  • TAP block
  • pyeloplasty
  • erector spina plane block
  • transversus abdominus plane block
  • flank incision
  • post-op analgesia
  • peri-op analgesia
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologist class I, II or III
  • Patients scheduled for elective open pyeloplasty surgery

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugBupivacaine

    0.5 ml/kg 0.25% bupivacaine

06

What researchers measure

Primary outcomes

  1. Remifentanil need

    Intraoperative remifentanil requirement as rescue analgesia

    Time frame: During the operation

  2. Post-operative analgesia need

    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

    Time frame: 24 hours post-operatively

Secondary outcomes

  1. Parental satisfaction with analgesia

    Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied

    Time frame: 24 hours post-operatively

07

Study locations

1 of 1 sites recruiting
  • Istanbul University Cerrahpasa Medical Faculty
    Istanbul, Please Select 34098, Turkey
    • Pinar Kendigelen, Assoc.Prof. · Contact · pinarken@gmail.com · +905325868734
    • Aybike Onur Gonen, MD · Contact · aybikeonur@gmail.com · +905322701086
    • Pınar Kendigelen, Assoc.Prof. · Principal investigator
    • Ayse C Tutuncu, Prof · Sub investigator
    • Guner Kaya, Prof · Sub investigator
    • Aybike Onur Gonen, MD · Sub investigator
    • Rahsan Ozcan, Assoc.Prof. · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03790566
Lead sponsor
Istanbul University
Collaborators
Aybike Onur Gonen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D., Rahsan Ozcan
Responsible party
pinar kendigelen (Assoc. Prof., Istanbul University) — Principal investigator
First posted
Dec 31, 2018
Start date
Feb 20, 2019
Primary completion
Sep 2, 2019 (estimated)
Completion
Sep 25, 2019 (estimated)
Last update
Feb 26, 2019

Study contacts

Pinar Kendigelen, Assoc. Prof.
Contact
pinarken@gmail.com
+905325868734
Aybike Onur Gonen, MD
Contact
aybikeonur@gmail.com
+905322701086
Pinar Kendigelen, Assoc. Prof.
principal investigator · Istanbul University Cerrahpasa Medical Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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