Clinical trial NCT03790566: Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases
Official title: Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Aybike Onur Gonen
name: Ayse Cigdem Tutuncu
name: Kaya, Guner, M.D.
name: Rahsan Ozcan
First posted: 2018-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Remifentanil need
timeFrame: During the operation
measure: Post-operative analgesia need
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: Parental satisfaction with analgesia
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
state: Please Select
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Pinar Kendigelen, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: