NCT03693222

Brief Summary

Quadratus lumborum block (QLB) is a newly-defined trunk block performed with local anesthetic injection by imaging the abdominal muscles with ultrasonography (US) guidance; thus, analgesia is expected to be ensured from the T7-L1 dermatomal segment level. In the study, the aim was to compare the postoperative analgesic effect of quadratus lumborum block in pediatric patients undergoing lower abdominal surgery

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable postoperative-pain

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

May 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

October 4, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 7, 2018

Last Update Submit

October 3, 2018

Conditions

Keywords

Quadratus lumborum block, abdominal trunk block

Outcome Measures

Primary Outcomes (1)

  • postoperative total analgesic amounts in 24 hours

    the number of analgesic requirements

    how many times in 24 hours

Secondary Outcomes (1)

  • first analgesic requirement times

    in 24 hours

Study Arms (2)

tramadol use

EXPERIMENTAL

Cases were assessed as intravenous opioid with 1 mg/kg tramadol hydrochloride

Drug: Tramadol HydrochlorideDrug: Morphine Sulfate

quadratus lumborum block

EXPERIMENTAL

Cases were assessed asquadratus lumborum block for postoperative analgesia

Drug: Tramadol HydrochlorideDrug: Morphine Sulfate

Interventions

The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.

quadratus lumborum blocktramadol use

The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.

quadratus lumborum blocktramadol use

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with ASA (American Society of Anesthesiologist) I-II level.

You may not qualify if:

  • Cases with ASA III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

TramadolMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator's study is a prospective, randomized, double-blind study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

October 2, 2018

Study Start

May 15, 2016

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

October 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share