PainNCT05684471
SFIB vs Anterior QLB in Total Hip Arthroplasty
A study testing Ultrasound Guided Suprainguinal Fascia iliaca Block and Ultrasound Guided Anterior Quadratus Lumborum Block in people with Pain, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Quadratus lumborum block (QLB) is a facial plane block defined to provide analgesia from T7-L3 dermatomes. There are articles reporting that it is an effective analgesic method in hip surgeries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Ultrasound Guided Suprainguinal Fascia iliaca Block and Ultrasound Guided Anterior Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2023to 7 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for total hip artroplasty surgery under spinal anesthesia
Who cannot join
- Patients who did not want to participate in the study
- Patients with cognitive dysfunction who cannot evaluate the NRS score and cannot use PCA
- Known local anesthetics and opioid allergy,
- Pregnancy or lactation
- Patients with a contraindication to spinal and regional anesthesia
- Presence of multiple fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block in Patients Undergoing Total Hip Arthroplasty Under Spinal Anesthesia
Quadratus lumborum block (QLB) is a facial plane block defined to provide analgesia from T7-L3 dermatomes. There are articles reporting that it is an effective analgesic method in hip surgeries. Suprainguinal fascia iliaca block (SIFIB) also blocks components of the lumbar plexus and provides effective analgesia in hip surgeries. The investigators aim to compare the effectiveness of QLB and SIFIB in patients undergoing primary total hip arthroplasty (THA).
- Conditions
- Pain
- Being tested
- Ultrasound Guided Suprainguinal Fascia iliaca Block, Ultrasound Guided Anterior Quadratus Lumborum Block
- Keywords
- Postoperative pain management, Total hip arthroplasty, Suprainguinal fascia iliaca block, Anterior QLB
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Suprainguinal Fascia iliaca BlockProcedure or surgery
Patients in this group will be administered SFIB with 50 mL of local anesthetic solution (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed.
Ultrasound Guided Anterior Quadratus Lumborum BlockProcedure or surgery
Patients in this group will be administered anterior QLB with 40 mL of local anesthetic (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Suprainguinal Fascia iliaca Block | Active comparator | Patients randomized to receive suprainguinal fascia iliaca block Receives: Procedure: Ultrasound Guided Suprainguinal Fascia iliaca Block |
| Ultrasound Guided Anterior quadratus lumborum block | Active comparator | Patients randomized to receive anterior quadratus lumborum block Receives: Procedure: Ultrasound Guided Anterior Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid comsumption
Morphine consumptions for both group will be recorded
Measured: up to 24 hour
Secondary outcomes (3)
Numeric rating scale for postoperative pain intensity
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. (3-6-12-18-24th hour) NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: up to 24 hours
Quality of Recovery (QoR-15)
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. The QoR-15 scale is a patient-based outcome measure in the form of a 15-item validated questionnaire.
Measured: at 24th hour
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start18 Jan 2023
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Tulgar, Samsun University
- Investigators
- Serkan Tulgar, Principal investigator, Samsun Üniversitesi tıp fakültesi, Samsun Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684471
- Sponsor's protocol ID
- LINRA
- Status last verified
- May 2024
- First submitted
- 5 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
James M, Bentley RA, Womack J, Goodman BA. Safety profile and outcome after ultrasound-guided suprainguinal fascia iliaca catheters for hip fracture: a single-centre propensity-matched historical cohort study. Can J Anaesth. 2022 Sep;69(9):1139-1150. doi: 10.1007/s12630-022-02279-0. Epub 2022 Jul 12.
PubMed 35819630Wang Q, Hu J, Zhang W, Zeng Y, Yang J, Kang P. Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block for Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Apr;37(4):763-769. doi: 10.1016/j.arth.2022.01.011. Epub 2022 Jan 11.
PubMed 35026362Shamim R, Prasad G, Bais PS, Priya V, Singh TK, Ambasta S, Philips AK. Ultrasound-Guided Suprainguinal Fascia Iliaca Compartment Block for Postoperative Analgesia in Patients Undergoing Hip and Femur Surgeries: A Retrospective Analysis. Anesth Essays Res. 2020 Jul-Sep;14(3):525-530. doi: 10.4103/aer.AER_9_21. Epub 2021 Mar 22.
PubMed 34092870
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block in Patients Undergoing Total Hip Arthroplasty Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05684471
- Acronym / sponsor ID
- LINRA
- Conditions
- Pain
- Keywords
- Postoperative pain management, Total hip arthroplasty, Suprainguinal fascia iliaca block, Anterior QLB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 13 Jan 2023 (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.
Quadratus lumborum block (QLB) is a facial plane block defined to provide analgesia from T7-L3 dermatomes. There are articles reporting that it is an effective analgesic method in hip surgeries. Suprainguinal fascia iliaca block (SIFIB) also blocks components of the lumbar plexus and provides effective analgesia in hip surgeries. The investigators aim to compare the effectiveness of QLB and SIFIB in patients undergoing primary total hip arthroplasty (THA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Suprainguinal Fascia iliaca Block | Active comparator | Procedure: Ultrasound Guided Suprainguinal Fascia iliaca BlockPatients randomized to receive suprainguinal fascia iliaca block |
| Ultrasound Guided Anterior quadratus lumborum block | Active comparator | Procedure: Ultrasound Guided Anterior Quadratus Lumborum BlockPatients randomized to receive anterior quadratus lumborum block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for total hip artroplasty surgery under spinal anesthesia
Key exclusion criteria (6 listed)
- Patients who did not want to participate in the study
- Patients with cognitive dysfunction who cannot evaluate the NRS score and cannot use PCA
- Known local anesthetics and opioid allergy,
- Pregnancy or lactation
- Patients with a contraindication to spinal and regional anesthesia
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 Guided Suprainguinal Fascia iliaca BlockPatients in this group will be administered SFIB with 50 mL of local anesthetic solution (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed. | Procedure or surgery | Ultrasound Guided Suprainguinal Fascia iliaca Block |
| Ultrasound Guided Anterior Quadratus Lumborum BlockPatients in this group will be administered anterior QLB with 40 mL of local anesthetic (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed. | Procedure or surgery | Ultrasound Guided Anterior quadratus lumborum block |
Primary outcome
Cumulative opioid comsumption
Time frame: up to 24 hour
Morphine consumptions for both group will be recorded
3 secondary outcomes
Numeric rating scale for postoperative pain intensity
Time frame: up to 24 hours
Quality of Recovery (QoR-15)
Time frame: at 24th hour
Presence of quadriceps motor block (defined as paralysis or paresis).
Time frame: up to 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 8 May 2024.
- Background: PubMed 35819630James M, Bentley RA, Womack J, Goodman BA. Safety profile and outcome after ultrasound-guided suprainguinal fascia iliaca catheters for hip fracture: a single-centre propensity-matched historical cohort study. Can J Anaesth. 2022 Sep;69(9):1139-1150. doi: 10.1007/s12630-022-02279-0. Epub 2022 Jul 12.
- Background: PubMed 35026362Wang Q, Hu J, Zhang W, Zeng Y, Yang J, Kang P. Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block for Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Apr;37(4):763-769. doi: 10.1016/j.arth.2022.01.011. Epub 2022 Jan 11.
- Background: PubMed 34092870Shamim R, Prasad G, Bais PS, Priya V, Singh TK, Ambasta S, Philips AK. Ultrasound-Guided Suprainguinal Fascia Iliaca Compartment Block for Postoperative Analgesia in Patients Undergoing Hip and Femur Surgeries: A Retrospective Analysis. Anesth Essays Res. 2020 Jul-Sep;14(3):525-530. doi: 10.4103/aer.AER_9_21. Epub 2021 Mar 22.
- 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.
Serkan Tulgar principal investigator
Samsun Üniversitesi tıp fakültesi, Samsun Eğitim ve Araştırma Hastanesi
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 Guided Suprainguinal Fascia iliaca Block and Ultrasound Guided Anterior Quadratus Lumborum Block in people with Pain, run by Samsun University 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 8 May 2024. 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?
Cumulative opioid comsumption (time frame: up to 24 hour). 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 NCT05684471, which also lists 3 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 8 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.