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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790566
Other study ID # 72109855-604.01.01-53213
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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