AnalgesiaNCT06054945
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
An observational study of Analgesia and Pain Management, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia, Pain Management, Acute Pain
- What is being tested?
- SIFIB (suprainguinal fascia iliaca block) and IPACK (Interspace between the popliteal artery and capsule of the posterior knee )
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2023to 15 Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: data of patients underwent total knee arthroplasty under spinal anesthesia between 01.01.2023 and 01.09.2023
Who may be able to join
- Patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study
- Patients underwent total knee arthroplasty (TKA)
- ASA class I to III.
- operated under spinal anesthesia
- patient controlled analjgesia device was used for analgesia
Who cannot join
- Patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis.
- PCA device problems in follow up in 24 hours
- anesthesia plans were converted to general anesthesia
- spinal anesthesia failure
- peripheral blocks used other than protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block in Knee Arthroplasty Patients Under Spinal Anesthesia: A Retrospective Cohort Study
In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the IPACK block enhances the quality of analgesia.
Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. Postoperative pain management is crucial for patient comfort and overall recovery.
In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1, 2023, and September 1, 2023.
- Conditions
- Analgesia, Pain Management, Acute Pain
- Being tested
- SIFIB (suprainguinal fascia iliaca block), IPACK (Interspace between the popliteal artery and capsule of the posterior knee ), Patient controlled anagesia device
- Keywords
- analgesia, IPACK, SIFIB
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIFIB (suprainguinal fascia iliaca block)Procedure or surgery
Ultrasound guided Suprainguinal Fascia Iliaca Block for Knee Arthroplasty Patients
IPACK (Interspace between the popliteal artery and capsule of the posterior knee )Other
Ultrasound guided IPACK (Interspace between the popliteal artery and capsule of the posterior knee ) Block for Knee Arthroplasty Patients
Patient controlled anagesia deviceDevice
Also called PCA
Those who were administered opioids with PCA as rescue analgesic in the postoperative analgesia plan on the selected dates will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| SIFIB | Patients who underwent SIFIB in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. Receives: Procedure: SIFIB (suprainguinal fascia iliaca block); Device: Patient controlled anagesia device | |
| SIFIB+IPACK | Patients who underwent SIFIB+IPACK blocks in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. Receives: Procedure: SIFIB (suprainguinal fascia iliaca block); Other: IPACK (Interspace between the popliteal artery and capsule of the posterior knee ); Device: Patient controlled anagesia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Opioid consumption via PCA device
Measured: 24 hours
Secondary outcomes (1)
NRS scores
NRS scores in different time frames. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start3 Sep 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Kusderci, M.D., Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054945
- Sponsor's protocol ID
- SIFIB+IPACK
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block in Knee Arthroplasty Patients Under Spinal Anesthesia: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06054945
- Acronym / sponsor ID
- SIFIB+IPACK
- Conditions
- Analgesia, Pain Management, Acute Pain
- Keywords
- analgesia, IPACK, SIFIB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 26 Sep 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.
In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the IPACK block enhances the quality of analgesia.
Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. Postoperative pain management is crucial for patient comfort and overall recovery.
In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1, 2023, and September 1, 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIFIB | – | Procedure: SIFIB (suprainguinal fascia iliaca block), Device: Patient controlled anagesia devicePatients who underwent SIFIB in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. |
| SIFIB+IPACK | – | Procedure: SIFIB (suprainguinal fascia iliaca block), Other: IPACK (Interspace between the popliteal artery and capsule of the posterior knee ), Device: Patient controlled anagesia devicePatients who underwent SIFIB+IPACK blocks in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- data of patients underwent total knee arthroplasty under spinal anesthesia between 01.01.2023 and 01.09.2023
Key inclusion criteria (5 listed)
- Patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study
- Patients underwent total knee arthroplasty (TKA)
- ASA class I to III.
- operated under spinal anesthesia
- patient controlled analjgesia device was used for analgesia
Key exclusion criteria (5 listed)
- Patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis.
- PCA device problems in follow up in 24 hours
- anesthesia plans were converted to general anesthesia
- spinal anesthesia failure
- peripheral blocks used other than protocol
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 |
|---|---|---|
| SIFIB (suprainguinal fascia iliaca block)Ultrasound guided Suprainguinal Fascia Iliaca Block for Knee Arthroplasty Patients | Procedure or surgery | SIFIB, SIFIB+IPACK |
| IPACK (Interspace between the popliteal artery and capsule of the posterior knee )Ultrasound guided IPACK (Interspace between the popliteal artery and capsule of the posterior knee ) Block for Knee Arthroplasty Patients | Other | SIFIB+IPACK |
| Patient controlled anagesia deviceAlso: PCAThose who were administered opioids with PCA as rescue analgesic in the postoperative analgesia plan on the selected dates will be included in the study. | Device | SIFIB, SIFIB+IPACK |
Primary outcome
Opioid consumption
Time frame: 24 hours
Opioid consumption via PCA device
1 secondary outcome
NRS scores
Time frame: 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 29 Sep 2023.
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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.
Hatice Kusderci, M.D. principal investigator
Samsun University
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 Analgesia and Pain Management, 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 5 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 29 Sep 2023. 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?
Opioid consumption (time frame: 24 hours). 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 29 Sep 2023.