Quadratus Lumborum Block in Pediatric Patients

NCT ID: NCT03693222

Last Updated: 2018-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2016-11-15

Brief Summary

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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

Detailed Description

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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).

Total analgesic amounts in 24 hours and first analgesic requirement times recorded.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The investigator's study is a prospective, randomized, double-blind study.

Study Groups

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tramadol use

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

Group Type EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type DRUG

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.

Morphine Sulfate

Intervention Type DRUG

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 block

Cases were assessed asquadratus lumborum block for postoperative analgesia

Group Type EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type DRUG

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.

Morphine Sulfate

Intervention Type DRUG

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.

Interventions

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Tramadol Hydrochloride

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.

Intervention Type DRUG

Morphine Sulfate

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BakirkoySadiKonuk

Identifier Type: -

Identifier Source: org_study_id

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