NCT03701126

Brief Summary

The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 1, 2018

Last Update Submit

October 6, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time for first analgesic request

    by investigator till hospital discharge, then through telephone with parents after discharge

    24 hours after surgery

Secondary Outcomes (4)

  • Total Opioid consumpsion

    During operation

  • Total Ibuprofen consumption

    24 hours after surgery

  • post operative pain score.

    2 , 4 , 8 , 12 & 24 hours after surgery.

  • parents satisfaction score.

    24 hours after surgery

Study Arms (2)

group A

ACTIVE COMPARATOR

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Procedure: Transversus Abdominis Plane BlockDrug: Bupivacaine 0.25% Injectable SolutionDevice: Ultra-sound guidance

group B

ACTIVE COMPARATOR

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Procedure: Caudal BlockDrug: Bupivacaine 0.25% Injectable SolutionDevice: Ultra-sound guidance

Interventions

Transversus Abdominis Plane BlockPROCEDURE

ultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).

group A
Caudal BlockPROCEDURE

ultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).

group B
Bupivacaine 0.25% Injectable SolutionDRUG

Dose 1ml /kg of patient body weight

group Agroup B
Ultra-sound guidanceDEVICE

using superficial high frequency probe to guide regional anesthesia

group Agroup B

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA (American society of anesthiologists) physical status grade I-II.
  • Operations not extending more than two hours.
  • Unilateral surgeries.

You may not qualify if:

  • Refusal of parents.
  • Urgent cases.
  • Bilateral or Complicated hernias (i.e., obstructed, strangulated, irreducible …).
  • Other contraindication of regional anesthesia e.g. septic focus at site of injection, patients on anticoagulant therapy or suffering from coagulopathy, allergy to local anesthetic drug.
  • Prolonged operations more than two hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Zagazig University.

Zagazig, Alsharkia, 44519, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohammed A Refky, MD

    Faculty of medicine, zagazig university, Egypt

    STUDY CHAIR

  • Doaa M Farid, MD

    Faculty of medicine, zagazig university, Egypt

    STUDY CHAIR

  • Ayat A Amer, MD

    Faculty of medicine, zagazig university, Egypt

    STUDY DIRECTOR

Central Study Contacts

Mohammed AS Mekawy, MSc

CONTACT

+201154183388mmekawy40@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 9, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)