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

I

Istanbul University

Status

Unknown

Conditions

Urologic Surgical Procedures
Pediatrics
Anesthesia and Analgesia

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03790566
72109855-604.01.01-53213

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Erector spinae plane block
Experimental group
Description:
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.
Treatment:
Drug: Bupivacaine
Transversus abdominus plane block
Active Comparator group
Description:
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.
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Central trial contact

Pinar Kendigelen, Assoc. Prof.; Aybike Onur Gonen, MD

Data sourced from clinicaltrials.gov

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