NCT02723487

Brief Summary

The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

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 phase_2 postoperative-pain

Timeline
Completed

Started Apr 2016

Typical duration for phase_2 postoperative-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

March 14, 2016

Last Update Submit

December 6, 2017

Conditions

Postoperative Pain

Keywords

TAP blockpediatricLaparoscopicpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • pain score

    Children's Hospital Eastern Ontario Pain Scale

    12 hours postoperative

Secondary Outcomes (6)

  • Total intraoperative fentanyl consumption

    12 hours postoperative

  • number of participants with incidence of nausea

    12 hours postoperative

  • number of participants with incidence of hematoma

    12 hours postoperative

  • number of participants with incidence of infection

    12 hours postoperative

  • Total postoperative paracetamol consumption

    12 hours postoperative

  • +1 more secondary outcomes

Study Arms (3)

Group A

NO INTERVENTION

Control

Group B

ACTIVE COMPARATOR

patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.

Drug: Bupivacaine 0.125%

Group C

ACTIVE COMPARATOR

patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.

Drug: Bupivacaine 0.25%

Interventions

Bupivacaine 0.125%DRUG

Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.

Also known as: Plain marcaine
Group B
Bupivacaine 0.25%DRUG

Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.

Also known as: Plain marcaine
Group C

Eligibility Criteria

Age1 Year - 5 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAccording to type of surgery laparoscopic undescended testis
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II physical status patients.
  • Genders Eligible for Study :male.
  • All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
  • Duration of Laparoscopic procedure not exceeding 90 minutes.
  • Written informed consent from parent of guardian .

You may not qualify if:

  • Sensitivities to local anesthetics.
  • Significant renal, liver, or cardiac disease.
  • Surgery requiring an open procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

  • Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.

    PMID: 24918899BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Abdelrady s Ibrahim, MD

    Assistant profossor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive care

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 30, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

October 1, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations

EG(1)