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Completed

NCT Number: NCT03693222

Quadratus Lumborum Block in Pediatric Patients

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

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Key information

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tramadol Hydrochloride

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

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.

Primary outcomes

  1. postoperative total analgesic amounts in 24 hours

    Time frame: how many times in 24 hours

    the number of analgesic requirements

Secondary outcomes

  1. first analgesic requirement times

    Time frame: in 24 hours

    first analgesic requirement times (hours)

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Effect of Quadratus Lumborum Block on Postoperative Analgesic Requirements in Pediatric Patients: A Randomized Controlled Double Blinded Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2018
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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