Total Knee ArthroplastyKnee Pain, FunctionalityNCT05943080
Comparison of IPACK Block and PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty
A study testing PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline) and ACB ( 0.25% marcaine + %0.9 saline) in people with Total Knee ArthroplastyKnee Pain, Functionality, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
It was planned to determine the most effective single and/or combined use in daily use by evaluating the effect on pain control and functional status by combining the posterior capsuler infiltration (PCI) and interspace between the popliteal artery and the capsule of the posterior knee(IPACK block) performed during… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Total Knee ArthroplastyKnee Pain, Functionality
- What is being tested?
- PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline) and ACB ( 0.25% marcaine + %0.9 saline)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Dec 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performing total knee joint arthroplasty due to stage 4 gonarthrosis Agree to participate in the study Having signed the informed consent form
Who cannot join
- Presence of malignancy, infection, rheumatological disease Same side has had previous surgery Known psychiatric and/or neurological diseases Expenses due to any medication or substance use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adductor Canal Block Combined With IPACK Block and Adductor Canal Block Combined With PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty:A Prospective, Double-Blind, Randomized Controlled Study
It was planned to determine the most effective single and/or combined use in daily use by evaluating the effect on pain control and functional status by combining the posterior capsuler infiltration (PCI) and interspace between the popliteal artery and the capsule of the posterior knee(IPACK block) performed during total knee replacement surgery with the adductor canal block method.
In the randomized controlled study:
Read more
Group 1; By determining the anatomical landmarks to be applied by the intraoperative surgeon, PCI + Adductor canal block (ACB) without any additional imaging, Group 2; IPACK+ACB applied by the anesthesiologist with the help of post-operative USG, In Group 3, there are 3 groups in which only ACB application is made. VAS values and opioid consumption of the groups will be recorded as the primary outcome after the surgery.
As a secondary outcome, the 1st day rehabilitation initiation times and endurance of the patients With 1.2. and on Day 3 joint ranges of motion will be recorded.
Read the detailed description
Patients with end-stage knee osteoarthritis who were examined in our study institution and who could not respond to conservative treatment and who accepted total knee replacement (TDP) surgery will be included.
Patients will be divided into three groups by randomization: Preoperative range of motion and pain scores (VAS) of the patients will be recorded in the service examination room. By determining the anatomical landmarks to be applied by the intraoperative surgeon, they will be asked to choose one of the 3 groups in which PCI + ACB , group 2; ACB + IPACK applied by the anesthesiologist with the help of Post-operative USg, and group 3, in which only ACB application will be made, and this choice will not be known by the patient.
PCI; Perioperative application is performed in the anatomical space between the posterior capsule and the popliteal artery before implantation. In the application, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.
IPACK: Following the closure of the wound in the postoperative period, the application is made into the anatomical space between the posterior capsule and the popliteal artery with the help of USG. In the application, 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine is used with a 22G 10 cm needle.
ACB: For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve are visualized in the inguinal region with ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated.
VAS values and opioid consumption will be recorded as the primary outcome of the patients who are taken to the service after the surgical procedure performed under spinal anesthesia without the use of a tourniquet. Post-operative 3. Hour-12. Hour -24. Hour -48th hour and 72th hour VAS will be recorded. The total opioid consumption on the 1st, 2nd and 3rd days, when the patient needs analgesics (opioids) in the first postoperative hour will be noted.
As the Secondary Outcome, the patients' 1st day rehabilitation initiation times and their endurance are measured in 1.2. and on Day 3 joint ranges of motion will be recorded.
- Being tested
- PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), ACB ( 0.25% marcaine + %0.9 saline)
- Keywords
- Total Knee Arthroplasty,Knee Pain, Functionality after tka, Posterior knee analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)Drug
The application is made into the anatomical space between the posterior capsule and the popliteal artery before implantation.
IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)Drug
It is applied to the anatomical space between the posterior capsule and the popliteal artery with the help of USG.
ACB ( 0.25% marcaine + %0.9 saline)Drug
It is inserted into the adductor canal by simultaneous imaging of the needle, accompanied by ultrasonography, from the level just below the sartorius muscle.
| Study group | Role | What they receive |
|---|---|---|
| PCI + ACB Group | Experimental | Firstly, perioperative application is performed in the anatomical space between the posterior capsule and the popliteal artery before implantation. In the application, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, first of all, the femoral artery and nerve in the inguinal region are visualized while the patient is in the supine position, accompanied by ultrasonography. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated. Receives: Drug: PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline) |
| IPACK block + ACB Group | Experimental | First of all, for the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve in the inguinal region are visualized by ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoral arter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated. then ACB is performed with the help of USG in the anatomical space between the posterior capsule and the popliteal artery. In practice, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine. Receives: Drug: IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline); Drug: ACB ( 0.25% marcaine + %0.9 saline) |
| ACB Group (control) | Other | At the end of the operation by the anesthesiologist only adductor canal block is applied, while the patient is in the supine position, the femoral artery and nerve are visualized in the inguinal region under ultrasound guidance. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated.
VAS values and opioid consumption will be recorded as the primary outcome of the patients who are taken to the service after the surgical procedure performed under spinal anesthesia without the use of a tourniquet. Post-operative 3. Hour-12. Hour -24. Hours -48th hour and 72nd hour. Receives: Drug: ACB ( 0.25% marcaine + %0.9 saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 1 day before surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 3th hour after surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 8th hour after surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 12th hour after surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 24th hour after surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 48th hour after surgery]
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: [Time Frame: 72th hour after surgery]
opioid usage
usage vanalgesics (opioids) in the first postoperative hour
Measured: first hour of use
opioid comsuption
opioid consumption after surgery
Measured: [Time Frame: 24th hour after surgery]
opioid comsuption
opioid consumption after surgery
Measured: [Time Frame: 48th hour after surgery]
opioid comsuption
opioid consumption after surgery
Measured: [Time Frame: 72th hour after surgery]
Secondary outcomes (4)
Measuring knee Joint Range of Motion
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: [Time Frame: 1 day before surgery]
Measuring knee Joint Range of Motion
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: [Time Frame: 1 days after before surgery]
Measuring knee Joint Range of Motion
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: [Time Frame: 3 days after surgery]
Measuring knee Joint Range of Motion
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: [Time Frame: 10 days after surgery]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2023
- Primary completion10 Aug 2023
- Study completion15 Dec 2023
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 Total Knee ArthroplastyKnee Pain, FunctionalityStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Fevzi Cakmak, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943080
- Sponsor's protocol ID
- 2023-12/86
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
PubMed 22357571Niesen AD, Harris DJ, Johnson CS, Stoike DE, Smith HM, Jacob AK, Amundson AW, Pawlina W, Martin DP. Interspace between Popliteal Artery and posterior Capsule of the Knee (IPACK) Injectate Spread: A Cadaver Study. J Ultrasound Med. 2019 Mar;38(3):741-745. doi: 10.1002/jum.14761. Epub 2018 Sep 19.
PubMed 30232819Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
PubMed 29721648
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Canal Block Combined With IPACK Block and Adductor Canal Block Combined With PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty:A Prospective, Double-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05943080
- Acronym / sponsor ID
- 2023-12/86
- Keywords
- Total Knee Arthroplasty,Knee Pain, Functionality after tka, Posterior knee analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Jul 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.
It was planned to determine the most effective single and/or combined use in daily use by evaluating the effect on pain control and functional status by combining the posterior capsuler infiltration (PCI) and interspace between the popliteal artery and the capsule of the posterior knee(IPACK block) performed during total knee replacement surgery with the adductor canal block method.
In the randomized controlled study:
Group 1; By determining the anatomical landmarks to be applied by the intraoperative surgeon, PCI + Adductor canal block (ACB) without any additional imaging, Group 2; IPACK+ACB applied by the anesthesiologist with the help of post-operative USG, In Group 3, there are 3 groups in which only ACB application is made. VAS values and opioid consumption of the groups will be recorded as the primary outcome after the surgery.
As a secondary outcome, the 1st day rehabilitation initiation times and endurance of the patients With 1.2. and on Day 3 joint ranges of motion will be recorded.
Detailed description
Patients with end-stage knee osteoarthritis who were examined in our study institution and who could not respond to conservative treatment and who accepted total knee replacement (TDP) surgery will be included.
Patients will be divided into three groups by randomization: Preoperative range of motion and pain scores (VAS) of the patients will be recorded in the service examination room. By determining the anatomical landmarks to be applied by the intraoperative surgeon, they will be asked to choose one of the 3 groups in which PCI + ACB , group 2; ACB + IPACK applied by the anesthesiologist with the help of Post-operative USg, and group 3, in which only ACB application will be made, and this choice will not be known by the patient.
PCI; Perioperative application is performed in the anatomical space between the posterior capsule and the popliteal artery before implantation. In the application, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.
IPACK: Following the closure of the wound in the postoperative period, the application is made into the anatomical space between the posterior capsule and the popliteal artery with the help of USG. In the application, 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine is used with a 22G 10 cm needle.
ACB: For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve are visualized in the inguinal region with ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated.
VAS values and opioid consumption will be recorded as the primary outcome of the patients who are taken to the service after the surgical procedure performed under spinal anesthesia without the use of a tourniquet. Post-operative 3. Hour-12. Hour -24. Hour -48th hour and 72th hour VAS will be recorded. The total opioid consumption on the 1st, 2nd and 3rd days, when the patient needs analgesics (opioids) in the first postoperative hour will be noted.
As the Secondary Outcome, the patients' 1st day rehabilitation initiation times and their endurance are measured in 1.2. and on Day 3 joint ranges of motion will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| PCI + ACB Group | Experimental | Drug: PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)Firstly, perioperative application is performed in the anatomical space between the posterior capsule and the popliteal artery before implantation. In the application, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, first of all, the femoral artery and nerve in the inguinal region are visualized while the patient is in the supine position, accompanied by ultrasonography. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated. |
| IPACK block + ACB Group | Experimental | Drug: IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), Drug: ACB ( 0.25% marcaine + %0.9 saline)First of all, for the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve in the inguinal region are visualized by ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoral arter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated. then ACB is performed with the help of USG in the anatomical space between the posterior capsule and the popliteal artery. In practice, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine. |
| ACB Group (control) | Other | Drug: ACB ( 0.25% marcaine + %0.9 saline)At the end of the operation by the anesthesiologist only adductor canal block is applied, while the patient is in the supine position, the femoral artery and nerve are visualized in the inguinal region under ultrasound guidance. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated. VAS values and opioid consumption will be recorded as the primary outcome of the patients who are taken to the service after the surgical procedure performed under spinal anesthesia without the use of a tourniquet. Post-operative 3. Hour-12. Hour -24. Hours -48th hour and 72nd hour. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Performing total knee joint arthroplasty due to stage 4 gonarthrosis Agree to participate in the study Having signed the informed consent form
Key exclusion criteria (1 listed)
- Presence of malignancy, infection, rheumatological disease Same side has had previous surgery Known psychiatric and/or neurological diseases Expenses due to any medication or substance use
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 |
|---|---|---|
| PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)The application is made into the anatomical space between the posterior capsule and the popliteal artery before implantation. | Drug | PCI + ACB Group |
| IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)It is applied to the anatomical space between the posterior capsule and the popliteal artery with the help of USG. | Drug | IPACK block + ACB Group |
| ACB ( 0.25% marcaine + %0.9 saline)It is inserted into the adductor canal by simultaneous imaging of the needle, accompanied by ultrasonography, from the level just below the sartorius muscle. | Drug | ACB Group (control), IPACK block + ACB Group |
Primary outcome
Pain Intensity
Time frame: [Time Frame: 1 day before surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 3th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 8th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 12th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 24th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 48th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Time frame: [Time Frame: 72th hour after surgery]
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
opioid usage
Time frame: first hour of use
usage vanalgesics (opioids) in the first postoperative hour
opioid comsuption
Time frame: [Time Frame: 24th hour after surgery]
opioid consumption after surgery
opioid comsuption
Time frame: [Time Frame: 48th hour after surgery]
opioid consumption after surgery
opioid comsuption
Time frame: [Time Frame: 72th hour after surgery]
opioid consumption after surgery
4 secondary outcomes
Measuring knee Joint Range of Motion
Time frame: [Time Frame: 1 day before surgery]
Measuring knee Joint Range of Motion
Time frame: [Time Frame: 1 days after before surgery]
Measuring knee Joint Range of Motion
Time frame: [Time Frame: 3 days after surgery]
Measuring knee Joint Range of Motion
Time frame: [Time Frame: 10 days 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 7 Mar 2024.
- Background: PubMed 22357571Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
- Results publication: PubMed 30232819Niesen AD, Harris DJ, Johnson CS, Stoike DE, Smith HM, Jacob AK, Amundson AW, Pawlina W, Martin DP. Interspace between Popliteal Artery and posterior Capsule of the Knee (IPACK) Injectate Spread: A Cadaver Study. J Ultrasound Med. 2019 Mar;38(3):741-745. doi: 10.1002/jum.14761. Epub 2018 Sep 19.
- Results publication: PubMed 29721648Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
- 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 PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline), IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline) and ACB ( 0.25% marcaine + %0.9 saline) in people with Total Knee ArthroplastyKnee Pain, Functionality, run by Kirsehir Ahi Evran Universitesi 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 1 inclusion and 1 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 7 Mar 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?
Pain Intensity (time frame: [Time Frame: 1 day before surgery]). The study lists 11 primary outcomes in all. 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 NCT05943080, 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 7 Mar 2024.