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

Sponsor

Istanbul University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03790566

Collaborator

Aybike Onur Gonen (Other), Ayse Cigdem Tutuncu (Other), Guner Kaya (Other), Rahsan Ozcan (Other)

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia and Analgesia Pediatrics Urologic Surgical Procedures	Drug: Bupivacaine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 20, 2019

Anticipated Primary Completion Date :

Sep 2, 2019

Anticipated Study Completion Date :

Sep 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erector spinae plane block 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.	Drug: Bupivacaine 0.5 ml/kg 0.25% bupivacaine
Active Comparator: Transversus abdominus plane block 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.	Drug: Bupivacaine 0.5 ml/kg 0.25% bupivacaine

Arm

Intervention/Treatment

Experimental: Erector spinae plane block

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.

Drug: Bupivacaine

0.5 ml/kg 0.25% bupivacaine

Active Comparator: Transversus abdominus plane block

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.

Drug: Bupivacaine

0.5 ml/kg 0.25% bupivacaine

Outcome Measures

Primary Outcome Measures

Remifentanil need [During the operation]
Intraoperative remifentanil requirement as rescue analgesia
Post-operative analgesia need [24 hours post-operatively]
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

Secondary Outcome Measures

Parental satisfaction with analgesia [24 hours post-operatively]
Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied