Regional AnesthesiaNCT05450211
Evaluation of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block
A study testing Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) in people with Regional Anesthesia, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the postoperative analgesic efficacy of the suprainguinal fascia iliaca block applied in the postoperative period in terms of 24-hour opioid consumption, pain score, additional analgesic need, and side effects and complications in the postoperative period, and to see the postoperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 9 Nov 2022
- 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
- Having undergone unilateral knee replacement surgery under elective conditions,
- Age range of 18-75 years,
- ASA score I and II,
- Body mass index < 35kg/m²,
- written consent who agreed to participate in the study.
Who cannot join
- who do not want to be included in the study by not signing the voluntary consent form,
- Body mass index > 35 kg/m²,
- Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,
- Coagulopathy, hepatic or renal failure,
- Allergic to a local anesthetic agent or one of the drugs used in the study,
- Having a history of chronic opioid and corticosteroid use,
- who cannot use the patient-controlled analgesia system and have a psychiatric disease,
- with operative time less than 20 minutes and more than 120 minutes for better standardization of studies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Research and Education Hospital
Samsun, 55090
About this study
Official title: Evaluation of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block Applied With Ultrasonography in Knee Arthroplasty
It was aimed to evaluate the postoperative analgesic efficacy of the suprainguinal fascia iliaca block applied in the postoperative period in terms of 24-hour opioid consumption, pain score, additional analgesic need, and side effects and complications in the postoperative period, and to see the postoperative analgesic effectiveness of this block in patients who underwent knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery.
There are many studies in the literature showing successful results regarding the effectiveness of suprainguinal fascia iliaca block on postoperative pain in pain control after hip surgery. However, there is not enough information about the use of suprainguinal fascia iliaca block in knee arthroplasty. With this study, the investigators aim to contribute to the literature on the use and effectiveness of suprainguinal fascia iliaca block in knee arthroplasty.
An identification number (ID) number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participans will be followed up with these numbers in patient follow-up. Which group the participants will be included in will be determined by the closed envelope method.
Participants who underwent unilateral knee arthroplasty will be included in the prospective and randomized study. The participants will be divided into two groups and suprainguinal fascia iliaca block and patient-controlled analgesia (Group SFI) will be applied to one group and patient-controlled analgesia (Group PCA) will be applied to the other group.
No block attempt will be made to the participants in the patient-controlled analgesia group (Group PCA), and when the patient is taken to the recovery room after surgery, patient-controlled analgesia will be administered and transferred to the ward.
Group SFI; the block procedure will be applied to the participant lying in the supine position under sterile conditions with a high-frequency linear probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy).In the block method, 0.25% bupivacaine (Buvasin Vem İlaç, Turkey) (15 ml physiological saline + 15 ml 0.5% bupivacaine) total amount of 30 ml, same volume and same concentration will be used. The participant with the block will be followed in the recovery room and if the block is successful, PCA treatment will be started and the participant will be taken to the ward.
Evaluation of postoperative pain will be done with numerical rating scale (NRS).Pain levels will be questioned in two different ways as rest and passive moving.
- Conditions
- Regional Anesthesia
- Being tested
- Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy), Patient controlled analgesia
- Keywords
- regional analgesia, suprainguinal fascia iliaca block, patient controlled analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)Device
A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in group SFI.
Patient controlled analgesiaDevice
Patient-controlled analgesia will be used for pain control after surgery in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Group SFI (Suprainguinal fascia iliaca block) | Active comparator | In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with an 85 mm needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space.
When the patient whose block procedure is successful, is taken to the recovery room, controlled analgesia will be applied to the patient and he will be transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA. Receives: Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy); Device: Patient controlled analgesia |
| Group PCA (patient controlled analgesia) | Active comparator | No block attempt will be made to the patients in this group, and when the patient is taken to the recovery room after surgery, controlled analgesia will be administered and transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA. Receives: Device: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Numerical Rating Scale
To determine the pain of the patients at rest and passive moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.
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 posted8 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Oct 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Kefeli Celik, Samsun Education and Research Hospital
- Investigators
- Mustafa Suren, Professor, Study chair, Samsun Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450211
- Sponsor's protocol ID
- OYKU55
- Status last verified
- Nov 2022
- First submitted
- 5 Jul 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researched data and statistical analyzes will be available from the journal in which the clinical study was published.
Publications
Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
PubMed 28861197Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
PubMed 28059869Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
PubMed 21401544Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.
PubMed 30250982
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block Applied With Ultrasonography in Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05450211
- Acronym / sponsor ID
- OYKU55
- Conditions
- Regional Anesthesia
- Keywords
- regional analgesia, suprainguinal fascia iliaca block, patient controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 8 Jul 2022 (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.
It was aimed to evaluate the postoperative analgesic efficacy of the suprainguinal fascia iliaca block applied in the postoperative period in terms of 24-hour opioid consumption, pain score, additional analgesic need, and side effects and complications in the postoperative period, and to see the postoperative analgesic effectiveness of this block in patients who underwent knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery.
There are many studies in the literature showing successful results regarding the effectiveness of suprainguinal fascia iliaca block on postoperative pain in pain control after hip surgery. However, there is not enough information about the use of suprainguinal fascia iliaca block in knee arthroplasty. With this study, the investigators aim to contribute to the literature on the use and effectiveness of suprainguinal fascia iliaca block in knee arthroplasty.
An identification number (ID) number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participans will be followed up with these numbers in patient follow-up. Which group the participants will be included in will be determined by the closed envelope method.
Participants who underwent unilateral knee arthroplasty will be included in the prospective and randomized study. The participants will be divided into two groups and suprainguinal fascia iliaca block and patient-controlled analgesia (Group SFI) will be applied to one group and patient-controlled analgesia (Group PCA) will be applied to the other group.
No block attempt will be made to the participants in the patient-controlled analgesia group (Group PCA), and when the patient is taken to the recovery room after surgery, patient-controlled analgesia will be administered and transferred to the ward.
Group SFI; the block procedure will be applied to the participant lying in the supine position under sterile conditions with a high-frequency linear probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy).In the block method, 0.25% bupivacaine (Buvasin Vem İlaç, Turkey) (15 ml physiological saline + 15 ml 0.5% bupivacaine) total amount of 30 ml, same volume and same concentration will be used. The participant with the block will be followed in the recovery room and if the block is successful, PCA treatment will be started and the participant will be taken to the ward.
Evaluation of postoperative pain will be done with numerical rating scale (NRS).Pain levels will be questioned in two different ways as rest and passive moving.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SFI (Suprainguinal fascia iliaca block) | Active comparator | Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy), Device: Patient controlled analgesiaIn the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with an 85 mm needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space. When the patient whose block procedure is successful, is taken to the recovery room, controlled analgesia will be applied to the patient and he will be transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA. |
| Group PCA (patient controlled analgesia) | Active comparator | Device: Patient controlled analgesiaNo block attempt will be made to the patients in this group, and when the patient is taken to the recovery room after surgery, controlled analgesia will be administered and transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having undergone unilateral knee replacement surgery under elective conditions,
- Age range of 18-75 years,
- ASA score I and II,
- Body mass index < 35kg/m²,
- written consent who agreed to participate in the study.
Key exclusion criteria (8 listed)
- who do not want to be included in the study by not signing the voluntary consent form,
- Body mass index > 35 kg/m²,
- Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,
- Coagulopathy, hepatic or renal failure,
- Allergic to a local anesthetic agent or one of the drugs used in the study,
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 |
|---|---|---|
| Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in group SFI. | Device | Group SFI (Suprainguinal fascia iliaca block) |
| Patient controlled analgesiaPatient-controlled analgesia will be used for pain control after surgery in both groups. | Device | Group PCA (patient controlled analgesia), Group SFI (Suprainguinal fascia iliaca block) |
Primary outcome
Analgesic consumption
Time frame: Postoperative 24 hours
To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.
1 secondary outcome
Numerical Rating Scale
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 10 Nov 2022.
- Results publication: PubMed 28861197Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
- Results publication: PubMed 28059869Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- Results publication: PubMed 21401544Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
- Results publication: PubMed 30250982Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.
- Individual participant dataSharing planned: No. Researched data and statistical analyzes will be available from the journal in which the clinical study was published.
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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.
Mustafa Suren, Professor study chair
Samsun Research and Education 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 Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) in people with Regional Anesthesia, run by Samsun Education 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 5 inclusion and 8 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 10 Nov 2022. 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?
Analgesic consumption (time frame: Postoperative 24 hours). 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 NCT05450211, which also lists 4 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 10 Nov 2022.