Postoperative PainNCT04733313
Effect of Quadratus Lumborum Block in C/S
A study testing ultrasound guıded quadratus lumborum block in people with Postoperative Pain and Cesarean Section Complications, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Cesarean Section Complications, Block
- What is being tested?
- ultrasound guıded quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2017to 15 Aug 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
- obtained patients informed consent
Who cannot join
- inability to comprehend
- bleeding diathesis
- allergy to the study agents
- localized infection
- block failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Healt Science University Bursa Training and Research Hospita
Bursa, Yildirim, 16310
About this study
Official title: Comparison of Ultrasound Guided Quadratus Lumborum Block-2 and Quadratus Lumborum Block-3 for Postoperative Pain in Cesarean Section
to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.
- Being tested
- ultrasound guıded quadratus lumborum block
- Medical subject headings
- Pain, Postoperative, Bites and Stings, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guıded quadratus lumborum blockProcedure or surgery
Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum-2 | Active comparator | Not described Receives: Procedure: ultrasound guıded quadratus lumborum block |
| quadratus lumborum-3 | Active comparator | Not described Receives: Procedure: ultrasound guıded quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of postoperative pain
measure of the visual analog scale at rest and dynamic after surgery
Measured: during 24 hour after surgery
Secondary outcomes (1)
need of analgesic
total number of PCA demands
Measured: during 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Jul 2017
- Primary completion15 May 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ferit Yetik, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733313
- Sponsor's protocol ID
- 2017-7/8
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- 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
- Comparison of Ultrasound Guided Quadratus Lumborum Block-2 and Quadratus Lumborum Block-3 for Postoperative Pain in Cesarean Section
- ClinicalTrials.gov ID
- NCT04733313
- Acronym / sponsor ID
- 2017-7/8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 2 Feb 2021 (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.
to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum-2 | Active comparator | Procedure: ultrasound guıded quadratus lumborum block |
| quadratus lumborum-3 | Active comparator | Procedure: ultrasound guıded quadratus lumborum block |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
- obtained patients informed consent
Key exclusion criteria (5 listed)
- inability to comprehend
- bleeding diathesis
- allergy to the study agents
- localized infection
- block failure
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 |
|---|---|---|
| ultrasound guıded quadratus lumborum blockAdministering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection. | Procedure or surgery | quadratus lumborum-2, quadratus lumborum-3 |
Primary outcome
Assesment of postoperative pain
Time frame: during 24 hour after surgery
measure of the visual analog scale at rest and dynamic after surgery
1 secondary outcome
need of analgesic
Time frame: during 24 hour after surgery
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guıded quadratus lumborum block in people with Postoperative Pain and Cesarean Section Complications, 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 5 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?
Assesment of postoperative pain (time frame: during 24 hour after surgery). 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.