The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for PainPhase 1NCT06783712
Comparative Study Between Ultrasound-Guided IPACK Block (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) with Adductor Canal Block Versus Adductor Canal Block Alone for Postoperative Pain Management in Total Knee Arthroplasty
A Phase 1 study testing Adductor canal block and Adductor Canal Block (ACB) + iPACK Block in people with The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will compare the effectiveness of the interspace between the popliteal artery and posterior capsule of the knee (IPACK) block with adductor canal block versus adductor canal block alone for postoperative analgesia in total knee arthroplasty with consequently improved early ambulation and functional… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for Pain
- What is being tested?
- Adductor canal block and Adductor Canal Block (ACB) + iPACK Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2025to 1 Feb 2025
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
Who cannot join
- The patient refusal to give written consent.
- Previously known allergy to one of the drugs being used in the study.
- Physical status: ASA grades more than III
- History or evidence of coagulopathy, use of anti-coagulant or anti-platelet therapy.
- Patients with neuromuscular disorders
- Injection site infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Egypt, 11111
Hager Talal Mohamed, MBBCH, +201119050190, hager.talal5@gmail.com
Hager Talal Mohamed, MBBCH
About this study
The investigators will compare the effectiveness of the interspace between the popliteal artery and posterior capsule of the knee (IPACK) block with adductor canal block versus adductor canal block alone for postoperative analgesia in total knee arthroplasty with consequently improved early ambulation and functional rehabilitation.
Read the detailed description
A.Preoperative settings:
All patients will undergo preoperative assessment (including full history, clinical examination \& routine preoperative laboratory investigations will be done (CBC, INR, PT, PTT, and blood chemistry like liver and kidney functions).
B.Intraoperative settings:
On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. An intravenous (IV) cannula will be inserted, and 500 cc lactated Ringer will be started intravenously as co-load volume. Premedication of 0.02mg/kg of midazolam IV will be given for sedation. Patients will receive spinal anesthesia by the supervisors of the research using the standard technique in a sitting position under complete aseptic conditions using betadine 10%. Then using 4ml lidocaine 2% for local skin infiltration, then introducing a spinal needle 25G (Mercury TM) till getting cerebrospinal fluid (CSF) flow. After getting the CSF flow 12.5mg of heavy bupivacaine 0.5% (Sunny Pharmaceutical Industries, Egypt) will be injected. Then the patient will lie supine with a slight inclination of the head, and then an assessment of the level of spinal anesthesia will be done using cold touch test.
Group I (Adductor canal group): Patients will receive the ultrasound-guided Adductor canal block (ACB) by the supervisors of the research performed just after skin closure. ACB will be performed under complete aseptic conditions. Using a high frequency (6-15MHz) linear probe of an ultrasound machine (Sonosite turbo M, Bothell, Washington, USA) covered with a sterile sheath and 100 mm needle SonoPlex (B-Braun Medical Inc., Bethlehem, PA, USA). ACB block will be performed while the patient is in a supine position at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle, 100 mm needle SonoPlex will be advanced with the guidance of ultrasound in an in-plane technique and 20 ml bupivacaine (Marcaine) 0.25% will be injected.
Group II: The patients will receive ACB by the supervisors of the research just after skin closure as previously described in group I and then an IPACK block will be performed. IPACK block will be performed under complete aseptic precautions using the ultrasound machine with the high-frequency linear probe covered with a sterile sheath and 100 mm needle SonoPlex. IPACK block will be performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then the probe will be distally slided for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappear and the flat metaphysis appear. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml bupivacaine 0.25% will be injected incrementally as the needle is withdrawn.
- postoperative settings Vital data including mean arterial blood pressure, heart rate, and oxygen saturation will be recorded 5 minutes before injection of each block and 5 minutes after injection and postoperatively at intervals of 1, 2, 4, 6, 12, 18 \& 24 hours. Postoperative pain will be evaluated by a Numeric Rating Scale for pain (NRS Pain) which is an 11-point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain), and 7-10 (severe pain), 0-10 scale will be recorded every hour for the first 6 hours and every 2 hours for the rest of the first 24 hours. The time interval between the time of block injection and the time to the first rescue analgesia required (in case of NRS Pain score ≥4) will be measured. If the NRS Pain score is ≥4, patients will receive pethidine 30 mg IV. The total amount of analgesia that will be received in 24 hours postoperatively will be recorded. Assessing hemodynamic data and side effects such as nausea, vomiting, hypotension or hematoma at site of injection.
- Being tested
- Adductor canal block, Adductor Canal Block (ACB) + iPACK Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockProcedure or surgery
Group I: Patients will receive the ultrasound-guided Adductor canal block (ACB) by the supervisors of the research performed just after skin closure. ACB will be performed under complete aseptic conditions. Using a high frequency (6-15MHz) linear probe of an ultrasound machine (Sonosite turbo M, Bothell, Washington, USA) covered with a sterile sheath and 100 mm needle SonoPlex (B-Braun Medical Inc., Bethlehem, PA, USA). ACB block will be performed while the patient is in a supine position at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle, 100 mm needle SonoPlex will be advanced with the guidance of ultrasound in an in-plane technique and 20 ml bupivacaine (Marcaine) 0.25% will be injected.
Adductor Canal Block (ACB) + iPACK BlockProcedure or surgery
Group II: The patients will receive ACB by the supervisors of the research just after skin closure as previously described in group I and then an IPACK block will be performed. IPACK block will be performed under complete aseptic precautions using the ultrasound machine with the high-frequency linear probe covered with a sterile sheath and 100 mm needle SonoPlex. IPACK block will be performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then the probe will be distally slided for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappear and the flat metaphysis appear. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur,20 ml bupivacaine 0.25% will be injected incrementally
| Study group | Role | What they receive |
|---|---|---|
| Group I: Adductor canal block alone | Active comparator | Not described Receives: Procedure: Adductor canal block |
| Group II: IPACK block with Adductor canal block | Active comparator | Not described Receives: Procedure: Adductor Canal Block (ACB) + iPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time interval between injection of the block and the first rescue analgesia dose given
Measured: 24 hours from block injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start9 Jan 2025 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hager Talal Mohamed, MBBCH, Principal investigator, Anesthesia Resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783712
- Sponsor's protocol ID
- FMASU MS47/2024
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ultrasound-Guided IPACK Block (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) with Adductor Canal Block Versus Adductor Canal Block Alone for Postoperative Pain Management in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06783712
- Acronym / sponsor ID
- FMASU MS47/2024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Jan 2025 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Jan 2025 (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 will compare the effectiveness of the interspace between the popliteal artery and posterior capsule of the knee (IPACK) block with adductor canal block versus adductor canal block alone for postoperative analgesia in total knee arthroplasty with consequently improved early ambulation and functional rehabilitation.
Detailed description
A.Preoperative settings:
All patients will undergo preoperative assessment (including full history, clinical examination \& routine preoperative laboratory investigations will be done (CBC, INR, PT, PTT, and blood chemistry like liver and kidney functions).
B.Intraoperative settings:
On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. An intravenous (IV) cannula will be inserted, and 500 cc lactated Ringer will be started intravenously as co-load volume. Premedication of 0.02mg/kg of midazolam IV will be given for sedation. Patients will receive spinal anesthesia by the supervisors of the research using the standard technique in a sitting position under complete aseptic conditions using betadine 10%. Then using 4ml lidocaine 2% for local skin infiltration, then introducing a spinal needle 25G (Mercury TM) till getting cerebrospinal fluid (CSF) flow. After getting the CSF flow 12.5mg of heavy bupivacaine 0.5% (Sunny Pharmaceutical Industries, Egypt) will be injected. Then the patient will lie supine with a slight inclination of the head, and then an assessment of the level of spinal anesthesia will be done using cold touch test.
Group I (Adductor canal group): Patients will receive the ultrasound-guided Adductor canal block (ACB) by the supervisors of the research performed just after skin closure. ACB will be performed under complete aseptic conditions. Using a high frequency (6-15MHz) linear probe of an ultrasound machine (Sonosite turbo M, Bothell, Washington, USA) covered with a sterile sheath and 100 mm needle SonoPlex (B-Braun Medical Inc., Bethlehem, PA, USA). ACB block will be performed while the patient is in a supine position at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle, 100 mm needle SonoPlex will be advanced with the guidance of ultrasound in an in-plane technique and 20 ml bupivacaine (Marcaine) 0.25% will be injected.
Group II: The patients will receive ACB by the supervisors of the research just after skin closure as previously described in group I and then an IPACK block will be performed. IPACK block will be performed under complete aseptic precautions using the ultrasound machine with the high-frequency linear probe covered with a sterile sheath and 100 mm needle SonoPlex. IPACK block will be performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then the probe will be distally slided for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappear and the flat metaphysis appear. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml bupivacaine 0.25% will be injected incrementally as the needle is withdrawn.
- postoperative settings Vital data including mean arterial blood pressure, heart rate, and oxygen saturation will be recorded 5 minutes before injection of each block and 5 minutes after injection and postoperatively at intervals of 1, 2, 4, 6, 12, 18 \& 24 hours. Postoperative pain will be evaluated by a Numeric Rating Scale for pain (NRS Pain) which is an 11-point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain), and 7-10 (severe pain), 0-10 scale will be recorded every hour for the first 6 hours and every 2 hours for the rest of the first 24 hours. The time interval between the time of block injection and the time to the first rescue analgesia required (in case of NRS Pain score ≥4) will be measured. If the NRS Pain score is ≥4, patients will receive pethidine 30 mg IV. The total amount of analgesia that will be received in 24 hours postoperatively will be recorded. Assessing hemodynamic data and side effects such as nausea, vomiting, hypotension or hematoma at site of injection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Adductor canal block alone | Active comparator | Procedure: Adductor canal block |
| Group II: IPACK block with Adductor canal block | Active comparator | Procedure: Adductor Canal Block (ACB) + iPACK Block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- The patient refusal to give written consent.
- Previously known allergy to one of the drugs being used in the study.
- Physical status: ASA grades more than III
- History or evidence of coagulopathy, use of anti-coagulant or anti-platelet therapy.
- Patients with neuromuscular disorders
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 |
|---|---|---|
| Adductor canal blockGroup I: Patients will receive the ultrasound-guided Adductor canal block (ACB) by the supervisors of the research performed just after skin closure. ACB will be performed under complete aseptic conditions. Using a high frequency (6-15MHz) linear probe of an ultrasound machine (Sonosite turbo M, Bothell, Washington, USA) covered with a sterile sheath and 100 mm needle SonoPlex (B-Braun Medical Inc., Bethlehem, PA, USA). ACB block will be performed while the patient is in a supine position at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle, 100 mm needle SonoPlex will be advanced with the guidance of ultrasound in an in-plane technique and 20 ml bupivacaine (Marcaine) 0.25% will be injected. | Procedure or surgery | Group I: Adductor canal block alone |
| Adductor Canal Block (ACB) + iPACK BlockGroup II: The patients will receive ACB by the supervisors of the research just after skin closure as previously described in group I and then an IPACK block will be performed. IPACK block will be performed under complete aseptic precautions using the ultrasound machine with the high-frequency linear probe covered with a sterile sheath and 100 mm needle SonoPlex. IPACK block will be performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then the probe will be distally slided for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappear and the flat metaphysis appear. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur,20 ml bupivacaine 0.25% will be injected incrementally | Procedure or surgery | Group II: IPACK block with Adductor canal block |
Primary outcome
The time interval between injection of the block and the first rescue analgesia dose given
Time frame: 24 hours from block injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Yes
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.
Hager Talal Mohamed, MBBCH principal investigator
Anesthesia Resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adductor canal block and Adductor Canal Block (ACB) + iPACK Block in people with The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for Pain, run by Ain Shams University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 20 Jan 2025. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hager Talal Mohamed, MBBCH (+201119050190, hager.talal5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time interval between injection of the block and the first rescue analgesia dose given (time frame: 24 hours from block injection). 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 20 Jan 2025.