BlockNCT04094987
Interfascial Pressure Into Ultrasound Guided Anterior Quadratus Lumborum Block Application
A study testing inter-fascial pressure in people with Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Block
- What is being tested?
- inter-fascial pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2019to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Who cannot join
- Previous history of preoperative opioid use,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus
- Presence of infection in the block area,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
Official title: Investigation of the Effect of Interfacial Pressure on Block Success During Anterior Quadratus Lumborum Block Application
The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia.
In this block, local anesthetic drugs are administered between the quadratus lumborum (QL) muscle and the anterior leaf in the thoracolumbar fascia.
In this way, it has been reported that it provides a good analgesia as it relieves somatic pain better in upper and lower abdominal surgeries.
Read the detailed description
The mechanism of QLB analgesic contains many theories. This study includes the research relationship between the effect of fascial pressure and the success of the association block. We will use the ultrasound guided anterior Quadratus Lumborum Block. A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound.The pressure between the fascia and the pressure line added to the catheter tip will be measured.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound. The pressure between the fascia and the pressure line added to the catheter tip will be measured.
- Conditions
- Block
- Being tested
- inter-fascial pressure
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inter-fascial pressureDevice
The pressure between the fascia and the pressure line added to the catheter tip will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum block | Experimental | We will use the ultrasound guided anterior Quadratus Lumborum Block.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound Receives: Device: inter-fascial pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interfascial Pressure (mm/hg)
İnterfascial pressure will be measured the postoperative 24. hours through catheter.
Measured: 24 hours.
Secondary outcomes (3)
sensory block level
After the application, the sensory block level at the 30 minutes after the block application and 30 minutes after the operation will be determined by cold test.
Measured: peroperative 3 hours
Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
Measured: Postoperative 24 hours
analgesic use
analgesic use
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start29 Sep 2019
- Primary completion15 Oct 2019
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, cohort
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094987
- Sponsor's protocol ID
- 2011-KAEK-25 2019/05-26
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Interfacial Pressure on Block Success During Anterior Quadratus Lumborum Block Application
- ClinicalTrials.gov ID
- NCT04094987
- Acronym / sponsor ID
- 2011-KAEK-25 2019/05-26
- Conditions
- Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia.
In this block, local anesthetic drugs are administered between the quadratus lumborum (QL) muscle and the anterior leaf in the thoracolumbar fascia.
In this way, it has been reported that it provides a good analgesia as it relieves somatic pain better in upper and lower abdominal surgeries.
Detailed description
The mechanism of QLB analgesic contains many theories. This study includes the research relationship between the effect of fascial pressure and the success of the association block. We will use the ultrasound guided anterior Quadratus Lumborum Block. A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound.The pressure between the fascia and the pressure line added to the catheter tip will be measured.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound. The pressure between the fascia and the pressure line added to the catheter tip will be measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, cohort
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum block | Experimental | Device: inter-fascial pressureWe will use the ultrasound guided anterior Quadratus Lumborum Block.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Previous history of preoperative opioid use,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inter-fascial pressureThe pressure between the fascia and the pressure line added to the catheter tip will be measured. | Device | Quadratus Lumborum block |
Primary outcome
Interfascial Pressure (mm/hg)
Time frame: 24 hours.
İnterfascial pressure will be measured the postoperative 24. hours through catheter.
3 secondary outcomes
sensory block level
Time frame: peroperative 3 hours
Visual Analog Scale
Time frame: Postoperative 24 hours
analgesic use
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Block
RecruitingObservational study
Evaluation of Large Language Models in Parasternal Block Ultrasound Interpretation
Parasternal Block
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korgün Ökmen principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inter-fascial pressure in people with Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interfascial Pressure (mm/hg) (time frame: 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.