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

Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03790566
Acronym
ESPPOP
Enrollment
40
Registered
2018-12-31
Start date
2019-02-20
Completion date
2019-09-25
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DRUGBupivacaine

0.5 ml/kg 0.25% bupivacaine

Sponsors

Aybike Onur Gonen
CollaboratorUNKNOWN
Ayse Cigdem Tutuncu
CollaboratorOTHER
Kaya, Guner, M.D.
CollaboratorINDIV
Rahsan Ozcan
CollaboratorUNKNOWN
Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Remifentanil needDuring the operationIntraoperative remifentanil requirement as rescue analgesia
Post-operative analgesia need24 hours post-operativelyPain 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

MeasureTime frameDescription
Parental satisfaction with analgesia24 hours post-operativelyParents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied

Countries

Turkey (Türkiye)

Contacts

Primary ContactPinar Kendigelen, Assoc. Prof.
pinarken@gmail.com+905325868734
Backup ContactAybike Onur Gonen, MD
aybikeonur@gmail.com+905322701086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026