NCT03790566

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

December 28, 2018

Last Update Submit

February 25, 2019

Conditions

Anesthesia and AnalgesiaPediatricsUrologic Surgical Procedures

Keywords

ESP blockTAP blockpyeloplastyerector spina plane blocktransversus abdominus plane blockflank incisionpost-op analgesiaperi-op analgesia

Outcome Measures

Primary Outcomes (2)

  • Remifentanil need

    Intraoperative remifentanil requirement as rescue analgesia

    During the operation

  • 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 Outcomes (1)

  • Parental satisfaction with analgesia

    24 hours post-operatively

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL

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

Transversus abdominus plane block

ACTIVE COMPARATOR

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

Interventions

BupivacaineDRUG

0.5 ml/kg 0.25% bupivacaine

Erector spinae plane blockTransversus abdominus plane block

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologist class I, II or III
  • Patients scheduled for elective open pyeloplasty surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Please Select, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pinar Kendigelen, Assoc. Prof.

    Istanbul University Cerrahpasa Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinar Kendigelen, Assoc. Prof.

CONTACT

+905325868734pinarken@gmail.com

Aybike Onur Gonen, MD

CONTACT

+905322701086aybikeonur@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 28, 2018

First Posted

December 31, 2018

Study Start

February 20, 2019

Primary Completion

September 2, 2019

Study Completion

September 25, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

TU(1)