NCT05286190

Brief Summary

Pediatric inguinal hernia repair (IHR) candidates experiences ordinarily mild to moderate pain, rarely severe pain in the postoperative period. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are two effective postoperative analgesia options. In this randomized study, it is aimed to compare the effects of CEB and TAPB on postoperative pain scores, additional analgesic requirement, postoperative nausea and vomiting incidence, procedural complications, family and surgeon satisfaction, length of hospital stay, chronic pain development in pediatric bilateral open IHR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 9, 2022

Last Update Submit

March 28, 2022

Conditions

Regional AnesthesiaPostoperative Pain, Acute

Keywords

US guided Caudal Epidural BlockUS guided Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY)

    It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild, 4-7 as moderate, and 8-10 as severe pain.

    Up to 24 hours

Secondary Outcomes (7)

  • PONV (Postoperative nausea and vomiting)

    Up to 24 hours

  • Additional analgesic requirement

    Up to 24 hours

  • Family satisfaction

    Up to 24 hours

  • Surgeon satisfaction

    Up to 24 hours

  • Complications

    Up to 24 hours

  • +2 more secondary outcomes

Study Arms (2)

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

US-guided Transversus Abdominis Plane Block was applied with 0.5 ml/kg of %25 Bupivacaine at each side before the surgical incision

Drug: Bupivacaine 0.25% Injectable Solution

Caudal Epidural Block

ACTIVE COMPARATOR

US-guided Caudal Block was applied with 0.7ml/kg of %25 Bupivacaine before the surgical incision

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Bupivacaine 0.25% Injectable SolutionDRUG

Bupivacaine 0.25% Injectable Solution

Also known as: Marcaine
Caudal Epidural BlockTransversus Abdominis Plane Block

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • patients aged 1-7 years who were scheduled for elective bilateral open IHR included in the study

You may not qualify if:

  • Patients with relative or absolute contraindications to TAPB or CEB, patients with chronic constipation or chronic pain disorders that may affect the evaluation of postoperative pain scores, patients who underwent emergency surgery, and patients with a history of allergic reaction to local anesthetics were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meltem Savran Karadeniz

Istanbul, Fatih, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Polat H, Senturk E, Savran Karadeniz M, Bingul ES, Emre Demirel E, Erginel B, Tugrul KM. Effects of ultrasound guided caudal epidural and transversus abdominis plane block on postoperative analgesia in pediatric inguinal hernia repair surgeries. J Pediatr Urol. 2023 Apr;19(2):213.e1-213.e7. doi: 10.1016/j.jpurol.2022.11.005. Epub 2022 Nov 15.

    PMID: 36446689DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

October 1, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

TU(1)