Quadratus Lumborum Block in Pediatric Patients
Effect of Quadratus Lumborum Block on Postoperative Analgesic Requirements in Pediatric Patients: A Randomized Controlled Double Blinded Study
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started May 2016
Shorter than P25 for not_applicable postoperative-pain
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2016
CompletedFirst Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedOctober 4, 2018
August 1, 2018
6 months
August 7, 2018
October 3, 2018
Conditions
Keywords
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
EXPERIMENTALCases were assessed as intravenous opioid with 1 mg/kg tramadol hydrochloride
quadratus lumborum block
EXPERIMENTALCases were assessed asquadratus lumborum block for postoperative analgesia
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.
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.
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- 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