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

Pediatrics Clinical Trial

— ESPPOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790566
• Other study ID #: 72109855-604.01.01-53213
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: February 2019
• Source: Istanbul University
• Contact: Pinar Kendigelen, Assoc. Prof.
• Phone: +905325868734
• Email: pinarken[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 25, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia and Analgesia
• Pediatrics
• Urologic Surgical Procedures

Intervention

Drug:
• Bupivacaine
0.5 ml/kg 0.25% bupivacaine

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul	Please Select

Sponsors (5)

Lead Sponsor	Collaborator
Istanbul University	Aybike Onur Gonen, Ayse Cigdem Tutuncu, Guner Kaya, Rahsan Ozcan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil need	Intraoperative remifentanil requirement as rescue analgesia	During the operation
Primary	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	24 hours post-operatively
Secondary	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	24 hours post-operatively