Opioid ConsumptionNCT06838156
Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery
A study testing Bupivacain in people with Opioid Consumption and Pain Postoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Consumption, Pain Postoperative
- What is being tested?
- Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 1 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective patients scheduled for hip arthroplasty surgery
- Patient willingness to participate in the study
- Patients over 18 years age of, ASA I-II-III,
Who cannot join
- Patients not wanting to participate in the study
- Patients who do not want regional anesthesia technique
- Allergic or coagulated patients
- Patients with liver, kidney, lung, heart failure and septic patients
- Neurological disorder, history of convulsions
- ASA IV patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam Ve Sakura City Hospital
Başakşehir, Istanbul
About this study
Official title: Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery: A Randomized Controlled Trial
Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks.
- Conditions
- Opioid Consumption, Pain Postoperative
- Being tested
- Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called SIFI
Suprainguinal Fascia Iliaca Compartment block was performed with a linear probe placed over the inguinal ligament using a portable ultrasound device. After visualization of the femoral nerve, 30 ml of 0.25% bupivacaine was injected into the fascia iliaca overlying the iliopsoas muscle using an appropriate needle.
BupivacainDrug
Also called QLB Type 3
Quadratus Lumborum Type 3 block was performed using a portable ultrasound device with a linear probe placed between the costal margin and the iliac crest on the lateral abdominal wall. 30 ml of 0.25% bupivacaine was injected between the quadratus lumborum and psoas muscles using an appropriate needle.
| Study group | Role | What they receive |
|---|---|---|
| SIFI Group | Active comparator | Group of 30 patients who underwent SIFI block Receives: Drug: Bupivacain |
| QLB Type 3 | Active comparator | Group of 30 patients who underwent QLB block Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on pain score
Postoperative 24-hour Visual Analog Scale was measured. ( 0=best 10=worst)
Measured: At 1,2,4, 6, 12 and 24 hours after surgery
Secondary outcomes (1)
Opioid Consumption
Intravenous patient-controlled analgesia (PCA) with tramadol was administered to both groups in the postoperative period.
Measured: At 1,2,4, 6, 12 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Feb 2023
- Primary completion15 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid ConsumptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838156
- Sponsor's protocol ID
- GK-QLB-SIFI
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
PubMed 38762396Xia Q, Ding W, Lin C, Xia J, Xu Y, Jia M. Postoperative pain treatment with transmuscular quadratus lumborum block and fascia iliaca compartment block in patients undergoing total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2021 Jul 10;21(1):188. doi: 10.1186/s12871-021-01413-7.
PubMed 34243719
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06838156
- Acronym / sponsor ID
- GK-QLB-SIFI
- Conditions
- Opioid Consumption, Pain Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 20 Feb 2025 (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.
Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIFI Group | Active comparator | Drug: BupivacainGroup of 30 patients who underwent SIFI block |
| QLB Type 3 | Active comparator | Drug: BupivacainGroup of 30 patients who underwent QLB block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective patients scheduled for hip arthroplasty surgery
- Patient willingness to participate in the study
- Patients over 18 years age of, ASA I-II-III,
Key exclusion criteria (6 listed)
- Patients not wanting to participate in the study
- Patients who do not want regional anesthesia technique
- Allergic or coagulated patients
- Patients with liver, kidney, lung, heart failure and septic patients
- Neurological disorder, history of convulsions
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 |
|---|---|---|
| BupivacainAlso: SIFISuprainguinal Fascia Iliaca Compartment block was performed with a linear probe placed over the inguinal ligament using a portable ultrasound device. After visualization of the femoral nerve, 30 ml of 0.25% bupivacaine was injected into the fascia iliaca overlying the iliopsoas muscle using an appropriate needle. | Drug | SIFI Group |
| BupivacainAlso: QLB Type 3Quadratus Lumborum Type 3 block was performed using a portable ultrasound device with a linear probe placed between the costal margin and the iliac crest on the lateral abdominal wall. 30 ml of 0.25% bupivacaine was injected between the quadratus lumborum and psoas muscles using an appropriate needle. | Drug | QLB Type 3 |
Primary outcome
Effect on pain score
Time frame: At 1,2,4, 6, 12 and 24 hours after surgery
Postoperative 24-hour Visual Analog Scale was measured. ( 0=best 10=worst)
1 secondary outcome
Opioid Consumption
Time frame: At 1,2,4, 6, 12 and 24 hours 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 20 Feb 2025.
- Results publication: PubMed 38762396Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
- Results publication: PubMed 34243719Xia Q, Ding W, Lin C, Xia J, Xu Y, Jia M. Postoperative pain treatment with transmuscular quadratus lumborum block and fascia iliaca compartment block in patients undergoing total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2021 Jul 10;21(1):188. doi: 10.1186/s12871-021-01413-7.
- 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 Bupivacain in people with Opioid Consumption and Pain Postoperative, run by Başakşehir Çam & Sakura City 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 3 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 20 Feb 2025. 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?
Effect on pain score (time frame: At 1,2,4, 6, 12 and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838156, which also lists 2 linked publications.
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 20 Feb 2025.