Arthropathy of KneeNCT06125067
Fascia Iliaca Compartment Block and IPACK Block in Total Knee Arthroplasty
An observational study of Arthropathy of Knee and Analgesia, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators sought to compare the effectiveness of postoperative pain control between the standard intravenous multimodal analgesia procedure used in managing patients undergoing total knee surgery, who experience severe postoperative analgesia needs, and multimodal analgesia procedures that incorporate… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Arthropathy of Knee, Analgesia
- What is being tested?
- no peripheral block, Fascia Iliaca Compartment Block and iPACK Block
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Dec 2024
- Phase
- Observational
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In our study, which is planned as a retrospective file scanning and postoperative regional anesthesia follow-up form review, all patients who have undergone elective total knee arthroplasty surgery of Ankara Atatürk Sanatorium Training and Research Hospital in the last 1 year (between 01 March 2022 and 31 March 2023) will be included in the study. It is planned to examine 120 patient files in total.
Who may be able to join
- Patients who have undergone elective total knee surgery
- ASA I-III patients
Who cannot join
- Those <30 kg
- People under 18 years of age
- Patients with missing follow-up forms
- Patients with a history of chronic opioid or corticosteroid use
- Patients with a history of inflammatory gonathrosis
- Patients with synovectomy operation history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
About this study
Official title: Comparison of the Efficacy of Fascia Iliaca Compartment Block and IPACK Block for Postoperative Analgesia in Total Knee Arthroplasty Operation
The investigators sought to compare the effectiveness of postoperative pain control between the standard intravenous multimodal analgesia procedure used in managing patients undergoing total knee surgery, who experience severe postoperative analgesia needs, and multimodal analgesia procedures that incorporate ultrasound-guided peripheral nerve blocks (Fascia Iliaca Compartment Block or iPACK Block) during postoperative follow-up. The aim is to determine which procedure is more effective.
Read the detailed description
All patients who received a total knee replacement surgery conducted by orthopaedic surgeons at the operating theatre of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and underwent postoperative pain assessment by anaesthetists will be retrospectively reviewed as part of the study.
Postoperative pain management follow-up for patients who have undergone surgical procedures at Anaesthesiology and Reanimation Clinic is standard practice during patients hospitalization. Patients who have undergone painful and significant surgical procedures are typically given postoperative patient-controlled analgesia devices and are administered intravenous painkillers that are under the patient's control. As part of multimodal analgesia procedure, the investigators apply peripheral nerve blocks routinely to eligible patients, provided that the necessary criteria are met. Once the postoperative Anesthesiology and Reanimation clinic's follow-up form, the regional anaesthesia follow-up form, is completed, patients receive coordinated follow-up care from anaesthesiologists and surgical physicians in postoperative ward to monitor analgesic requirements and increase patient satisfaction. Hourly monitoring ensures that patients receive optimal care.
The aims of study to examine the effectiveness of these procedures. The investigators will include all patients who received elective total knee arthroplasty surgery in the operating room of Ankara Atatürk Sanatorium Training and Research Hospital within the past year (between 01 March 2022 and 31 March 2023) in retrospective file review and postoperative pain follow-up study.
- Conditions
- Arthropathy of Knee, Analgesia
- Being tested
- no peripheral block, Fascia Iliaca Compartment Block, iPACK Block
- Keywords
- Total Knee Arthroplasty, iPACK Block, Fascia Iliaca Compartment Block, Postoperative Pain, Peripheral Nerve Block
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no peripheral blockProcedure or surgery
No peripheral block was applied. Standard multimodal analgesia method was applied.
Fascia Iliaca Compartment BlockProcedure or surgery
Fascia Iliaca Compartment Block is performed with the patient in a supine position. A high-frequency (6-14 MHz) linear ultrasound probe is positioned transversely to locate the femoral artery in the inguinal crease. The hyperechoic femoral nerve is usually visualized lateral to the femoral artery, between the iliopsoas and fascia iliaca. The probe is manoeuvred in a cranial and caudal direction to capture high-quality images of the femoral nerve and fascia iliaca. Identification of the triangular-shaped sartorius muscle and anterior superior iliac spine (ASIS) is achieved by lateral movement of the probe. Post-skin disinfection, the needle tip is directed just beneath the fascia iliaca. Local anaesthetic is administered following negative pressure aspiration into the area. The local anaesthetic spreads towards the femoral nerve medially and towards the iliac process laterally.
iPACK BlockProcedure or surgery
During the iPACK procedure, the patient assumes a supine position with the lower extremity flexed at the knee and abducted at the hip (in frog-leg position). The ultrasound transducer is placed in the lower third of the medial thigh, and then pushed backward and downward to visualize the gap between the popliteal artery and the femoral shaft, straight above the femoral condyles. After ensuring that the needle tip is placed 2 cm beyond the lateral border of the artery, local anaesthetic solution is administrated in divided doses to infiltrate the tissue space. The needle is then withdrawn after confirming negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (no peripheral block applied) | No peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group Receives: Procedure: no peripheral block | |
| Fascia Iliaca Compartment Block Group | Fascia Iliaca Compartment block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. Receives: Procedure: Fascia Iliaca Compartment Block | |
| iPACK Block Group | iPACK block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. Receives: Procedure: iPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.
Measured: postoperative 24 hours score change
Secondary outcomes (1)
5-point likert satisfaction scale
The patient's satisfaction with postoperative pain treatment will be recorded. 5 options; very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied, very satisfied
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Apr 2024
- Primary completion31 Jul 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Onur Kucuk, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Onur KÜÇÜK, specialist, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125067
- Sponsor's protocol ID
- 2012-KAEK-15/2719
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2023
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Fascia Iliaca Compartment Block and IPACK Block for Postoperative Analgesia in Total Knee Arthroplasty Operation
- ClinicalTrials.gov ID
- NCT06125067
- Acronym / sponsor ID
- 2012-KAEK-15/2719
- Conditions
- Arthropathy of Knee, Analgesia
- Keywords
- Total Knee Arthroplasty, iPACK Block, Fascia Iliaca Compartment Block, Postoperative Pain, Peripheral Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Nov 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.
The investigators sought to compare the effectiveness of postoperative pain control between the standard intravenous multimodal analgesia procedure used in managing patients undergoing total knee surgery, who experience severe postoperative analgesia needs, and multimodal analgesia procedures that incorporate ultrasound-guided peripheral nerve blocks (Fascia Iliaca Compartment Block or iPACK Block) during postoperative follow-up. The aim is to determine which procedure is more effective.
Detailed description
All patients who received a total knee replacement surgery conducted by orthopaedic surgeons at the operating theatre of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and underwent postoperative pain assessment by anaesthetists will be retrospectively reviewed as part of the study.
Postoperative pain management follow-up for patients who have undergone surgical procedures at Anaesthesiology and Reanimation Clinic is standard practice during patients hospitalization. Patients who have undergone painful and significant surgical procedures are typically given postoperative patient-controlled analgesia devices and are administered intravenous painkillers that are under the patient's control. As part of multimodal analgesia procedure, the investigators apply peripheral nerve blocks routinely to eligible patients, provided that the necessary criteria are met. Once the postoperative Anesthesiology and Reanimation clinic's follow-up form, the regional anaesthesia follow-up form, is completed, patients receive coordinated follow-up care from anaesthesiologists and surgical physicians in postoperative ward to monitor analgesic requirements and increase patient satisfaction. Hourly monitoring ensures that patients receive optimal care.
The aims of study to examine the effectiveness of these procedures. The investigators will include all patients who received elective total knee arthroplasty surgery in the operating room of Ankara Atatürk Sanatorium Training and Research Hospital within the past year (between 01 March 2022 and 31 March 2023) in retrospective file review and postoperative pain follow-up study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (no peripheral block applied) | – | Procedure: no peripheral blockNo peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group |
| Fascia Iliaca Compartment Block Group | – | Procedure: Fascia Iliaca Compartment BlockFascia Iliaca Compartment block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. |
| iPACK Block Group | – | Procedure: iPACK BlockiPACK block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In our study, which is planned as a retrospective file scanning and postoperative regional anesthesia follow-up form review, all patients who have undergone elective total knee arthroplasty surgery of Ankara Atatürk Sanatorium Training and Research Hospital in the last 1 year (between 01 March 2022 and 31 March 2023) will be included in the study. It is planned to examine 120 patient files in total.
Key inclusion criteria (2 listed)
- Patients who have undergone elective total knee surgery
- ASA I-III patients
Key exclusion criteria (6 listed)
- Those <30 kg
- People under 18 years of age
- Patients with missing follow-up forms
- Patients with a history of chronic opioid or corticosteroid use
- Patients with a history of inflammatory gonathrosis
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 |
|---|---|---|
| no peripheral blockNo peripheral block was applied. Standard multimodal analgesia method was applied. | Procedure or surgery | Control Group (no peripheral block applied) |
| Fascia Iliaca Compartment BlockFascia Iliaca Compartment Block is performed with the patient in a supine position. A high-frequency (6-14 MHz) linear ultrasound probe is positioned transversely to locate the femoral artery in the inguinal crease. The hyperechoic femoral nerve is usually visualized lateral to the femoral artery, between the iliopsoas and fascia iliaca. The probe is manoeuvred in a cranial and caudal direction to capture high-quality images of the femoral nerve and fascia iliaca. Identification of the triangular-shaped sartorius muscle and anterior superior iliac spine (ASIS) is achieved by lateral movement of the probe. Post-skin disinfection, the needle tip is directed just beneath the fascia iliaca. Local anaesthetic is administered following negative pressure aspiration into the area. The local anaesthetic spreads towards the femoral nerve medially and towards the iliac process laterally. | Procedure or surgery | Fascia Iliaca Compartment Block Group |
| iPACK BlockDuring the iPACK procedure, the patient assumes a supine position with the lower extremity flexed at the knee and abducted at the hip (in frog-leg position). The ultrasound transducer is placed in the lower third of the medial thigh, and then pushed backward and downward to visualize the gap between the popliteal artery and the femoral shaft, straight above the femoral condyles. After ensuring that the needle tip is placed 2 cm beyond the lateral border of the artery, local anaesthetic solution is administrated in divided doses to infiltrate the tissue space. The needle is then withdrawn after confirming negative aspiration. | Procedure or surgery | iPACK Block Group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: postoperative 24 hours score change
NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.
1 secondary outcome
5-point likert satisfaction scale
Time frame: postoperative 24th hour
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 12 Dec 2024.
- 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.
Onur KÜÇÜK, specialist principal investigator
Ankara Ataturk Sanatorium 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?
An observational study of Arthropathy of Knee and Analgesia, run by Ankara Ataturk Sanatorium 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 12 Dec 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?
Numerical Rating Scale (NRS) (time frame: postoperative 24 hours score change). 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 12 Dec 2024.