Back to resultsQuadratus Lumborum Block in Pediatric Patients
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tramadol Hydrochloride
Morphine Sulfate
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain focused on measuring Quadratus lumborum block, abdominal trunk block
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tramadol use
quadratus lumborum block
Arm Description
Cases were assessed as intravenous opioid with 1 mg/kg tramadol hydrochloride
Cases were assessed asquadratus lumborum block for postoperative analgesia
Outcomes
Primary Outcome Measures
postoperative total analgesic amounts in 24 hours
the number of analgesic requirements
Secondary Outcome Measures
first analgesic requirement times
first analgesic requirement times (hours)
Full Information
NCT ID
NCT03693222
First Posted
August 7, 2018
Last Updated
October 3, 2018
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03693222
Brief Title
Quadratus Lumborum Block in Pediatric Patients
Official Title
Effect of Quadratus Lumborum Block on Postoperative Analgesic Requirements in Pediatric Patients: A Randomized Controlled Double Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2016 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Quadratus lumborum block, abdominal trunk block
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The investigator's study is a prospective, randomized, double-blind study.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tramadol use
Arm Type
Experimental
Arm Description
Cases were assessed as intravenous opioid with 1 mg/kg tramadol hydrochloride
Arm Title
quadratus lumborum block
Arm Type
Experimental
Arm Description
Cases were assessed asquadratus lumborum block for postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride
Intervention Description
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
Intervention Name(s)
Morphine Sulfate
Intervention Description
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 Outcome Measure Information:
Title
postoperative total analgesic amounts in 24 hours
Description
the number of analgesic requirements
Time Frame
how many times in 24 hours
Secondary Outcome Measure Information:
Title
first analgesic requirement times
Description
first analgesic requirement times (hours)
Time Frame
in 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quadratus Lumborum Block in Pediatric Patients
We'll reach out to this number within 24 hrs