NCT04552548

Brief Summary

The aim of the present study is to evaluate and compare the analgesic effect of ultrasound-guided Quadratus Lumborum Block with ultrasound-guided Transversus Abdominis plane block in pediatric Laparoscopic lower abdominal surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable 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

Study Start

First participant enrolled

October 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

August 31, 2020

Last Update Submit

July 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • quality of postoperative analgesia

    Postoperative Pain scores as FLACC score (face, legs, activity, cry and consolability)

    24 hours after surgery

Secondary Outcomes (2)

  • analgesic consumption

    24 hours

  • duration of analgesia

    24 hours after block

Study Arms (3)

Control group

NO INTERVENTION

the patients will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation)

TAP group

ACTIVE COMPARATOR

the patients will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.

Other: regional nerve block

quadratus lumborum group

ACTIVE COMPARATOR

the patients will receive bilateral quadratus lumborum block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.

Other: regional nerve block

Interventions

Abdominal field blocks have been used in anesthesia for surgery involving the anterior abdominal wall with ultrasound-guided technique. TAP block is a regional anesthetic technique that blocks neural afferents of the anterolateral abdominal wall. Using anatomical landmark guidance or with the aid of ultrasound (US), local anesthetic is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound-guided quadratus lumborum (QL) block is considered now as one of the novel truncal abdominal blocks, as it is effective in preventing somatic pain associated with upper and lower abdominal surgeries.

TAP groupquadratus lumborum group

Eligibility Criteria

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

You may qualify if:

  • ASA I-II physical status patients
  • Children scheduled for laparoscopic surgery
  • Duration of Laparoscopic procedure not exceeding 90 minutes

You may not qualify if:

  • Sensitivities to local anesthetics
  • Significant renal, liver, or cardiac disease
  • Surgery requiring an open procedure
  • Participants refusing regional block
  • Those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia
  • Children required emergency procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minya University

Minya, 61519, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 17, 2020

Study Start

October 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations