Adductor Canal BlockNCT07096375
Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Pain, Functional Recovery and Inflammatory Response After Knee Replacement
A study testing Adductor Canal Block (ACB) + iPACK Block in people with Adductor Canal Block and Total Knee Replacement Surgery, run by Ain Shams University.
Trial summary
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Adductor Canal Block, Total Knee Replacement Surgery, Functional Recovery
- What is being tested?
- Adductor Canal Block (ACB) + iPACK Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee replacement.
- ASA physical status I to III
- Sex (males and females).
- Age 20 - 70 years.
Who cannot join
- Patients undergoing bilateral or revision total knee replacement.
- ASA physical status more than III
- Age less than 20 or older than 70
- severe renal insufficiency ( Estimated Glomerular filtration rate eGFR < 15 mL/min/1.73 m2 ).
- history of arrhythmia or seizures.
- Hypersensitivity to local anesthetics.
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- Preexisting peripheral neuropathy and prior vascular surgery on femoral vessels on operated site.
- Infection near site of injection e.g. osteomyelitis, septic knee joint, etc.
- Patient refusal or with difficulties in comprehending numeric pain rating scale (NRS) pain scores
- Any contraindications for spinal anesthesia. (eg.: refusal of patients, coagulopathy, use of anticoagulants or antiplatelets...)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rana Magdy, Master contact
About this study
Official title: Competency of Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Postoperative Pain, Functional Recovery and Inflammatory Response After Total Knee Replacement
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively.
Read the detailed description
Postoperative Analgesia Management and Evaluation of Outcomes:
After the total knee arthroplasty ended, the patients will be transmitted to the post anaesthesia care unit (PACU). The same multimodal postoperative analgesia will be applied in the PACU in three groups, which will be consistent with ketorolac 50 mg every twelve hours and acetaminophen 1 g i.v. every eight hours will be both applied for 3 days. If the NRS score is higher than 4, 5 mg morphine will be administered as rescue analgesia. Eight mg of odanesteron will be given when severe nausea or vomiting occurs. Enoxaparin for four weeks postoperatively will be given as a thromboembolism prophylaxis. Finally, patients will be ambulated with the help of the walker after the first ten postoperative hours.
Assessment of outcomes:
Primary outcome:
Assessment of pain after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by Bromage scale and cold sensation.
The total cumulative dose of used morphine to control pain from the postoperative in post anaesthesia care unit and in orthopaedic wards. Also, total opioid consumption will be recorded at 0-6, 6-12, and 12-24 h after surgery as primary outcome of the study.
Secondary outcome:
The secondary outcomes including assessment of pain by visual analogue scale (VAS) will be done postoperatively at 8 hours, 12 hours and 24 hours postoperatively.
Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study (Bringuier et al., 2009).
As well as the range of motion and quadriceps strength will be measured to grade the functional recovery of the knee joint after surgery after the first ten hours postoperatively. The protractor will be used for the range of motion. The interval of activities will be recorded three times a day, 6 h apart, and i will use the best value as the day's value. The quadriceps strength will be measured by asking the patient to flex the hip and knee and the complete knee extension. The outcome assessor will use resistance to knee extension and palpated the thigh muscles to measure muscle strength. No muscle movement will score 0 points, no joint movement with muscle contraction will score 1 point, no gravity resistance with joint movement will score 2 points, gravity resistance will score 3 points, partial counterforce resistance with gravity resistance will score 4 points, and normal joint function will score 5 points.
Also, blood samples for neutrophil-lymphocytic ratio (NLR) and platelet-lymphocytic ratio (PLR) will be collected at 12 and 24 h after surgery.
- Being tested
- Adductor Canal Block (ACB) + iPACK Block, Adductor Canal Block (ACB) + iPACK Block (sham injection)
- Keywords
- IPACK block, Adductor Canal Block, Inflammatory Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block (ACB) + iPACK BlockProcedure or surgery
Also called Adductor Canal Block (ACB), IPACK block
Adductor Canal Block (ACB) in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gaugusing a 22-gauge 100-mm short-bevelled regional block needle.
IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration.
Adductor Canal Block (ACB) + iPACK Block (sham injection)Procedure or surgery
Also called Adductor Canal Block, IPACK Block (sham injection)
All patients will receive Adductor Canal Block in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gauge 100-mm short-bevelled regional block needle IPACK block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of normal saline will be injected after negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block (ACB) + IPACK block | Active comparator | Group A: 25 patients will receive adductor canal block under ultrasound using 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml bupivacaine 0.25% at the start of surgery.
IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration. Receives: Procedure: Adductor Canal Block (ACB) + iPACK Block |
| Adductor Canal Block (ACB) + IPACK (sham injection) | Sham comparator | Group B : 25 patients will receive Adductor canal block only under ultrasound guide using 20ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml of saline (sham injection) at the start of the surgery. The patients in Group B will receive ACB and IPACK block (sham injection) as described above. Receives: Procedure: Adductor Canal Block (ACB) + iPACK Block (sham injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.
Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.
Measured: At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery
Secondary outcomes (3)
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively
Assessment of pain ( by 11 point numeric pain rating scale) after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by modified Bromage scale and cold sensation. Assessment of pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperatively, patients will be asked to rate perceived pain using an 11-point Numeric Pain Rating Scale (NRS: 0= no pain and 10= worst pain) experienced at rest and during active flexion 45◦.
Measured: Postoperative Pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperative.
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively
Range of motion and quadriceps strength (by extent of knee extension) will be measured to grade the functional recovery of the knee joint after surgery after the first 10 hours postoperatively. The extent of knee extension will be used to quantify the range of motion (ROM). The interval of activities will be recorded three times a day with 6 hours apart.
Measured: Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.
Blood samples for neutrophil-lymphocytic ratio (NLR) (normal range in normal male and female are 0.43 - 2.75 and 0.37 - 2.87 respectively) and platelet-lymphocytic ratio (PLR) (normal range in male and female are 36.63 - 149.13 and 43.36 - 172.68 respectively) will be collected at 12 hours and 24 hours postoperative.
Measured: Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start20 Sep 2025 (estimated)
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor Canal BlockStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096375
- Sponsor's protocol ID
- MD187/2024
- Status last verified
- Nov 2024
- First submitted
- 15 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Competency of Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Postoperative Pain, Functional Recovery and Inflammatory Response After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT07096375
- Acronym / sponsor ID
- MD187/2024
- Keywords
- IPACK block, Adductor Canal Block, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 31 Jul 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 aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively.
Detailed description
Postoperative Analgesia Management and Evaluation of Outcomes:
After the total knee arthroplasty ended, the patients will be transmitted to the post anaesthesia care unit (PACU). The same multimodal postoperative analgesia will be applied in the PACU in three groups, which will be consistent with ketorolac 50 mg every twelve hours and acetaminophen 1 g i.v. every eight hours will be both applied for 3 days. If the NRS score is higher than 4, 5 mg morphine will be administered as rescue analgesia. Eight mg of odanesteron will be given when severe nausea or vomiting occurs. Enoxaparin for four weeks postoperatively will be given as a thromboembolism prophylaxis. Finally, patients will be ambulated with the help of the walker after the first ten postoperative hours.
Assessment of outcomes:
Primary outcome:
Assessment of pain after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by Bromage scale and cold sensation.
The total cumulative dose of used morphine to control pain from the postoperative in post anaesthesia care unit and in orthopaedic wards. Also, total opioid consumption will be recorded at 0-6, 6-12, and 12-24 h after surgery as primary outcome of the study.
Secondary outcome:
The secondary outcomes including assessment of pain by visual analogue scale (VAS) will be done postoperatively at 8 hours, 12 hours and 24 hours postoperatively.
Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study (Bringuier et al., 2009).
As well as the range of motion and quadriceps strength will be measured to grade the functional recovery of the knee joint after surgery after the first ten hours postoperatively. The protractor will be used for the range of motion. The interval of activities will be recorded three times a day, 6 h apart, and i will use the best value as the day's value. The quadriceps strength will be measured by asking the patient to flex the hip and knee and the complete knee extension. The outcome assessor will use resistance to knee extension and palpated the thigh muscles to measure muscle strength. No muscle movement will score 0 points, no joint movement with muscle contraction will score 1 point, no gravity resistance with joint movement will score 2 points, gravity resistance will score 3 points, partial counterforce resistance with gravity resistance will score 4 points, and normal joint function will score 5 points.
Also, blood samples for neutrophil-lymphocytic ratio (NLR) and platelet-lymphocytic ratio (PLR) will be collected at 12 and 24 h after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block (ACB) + IPACK block | Active comparator | Procedure: Adductor Canal Block (ACB) + iPACK BlockGroup A: 25 patients will receive adductor canal block under ultrasound using 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml bupivacaine 0.25% at the start of surgery. IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration. |
| Adductor Canal Block (ACB) + IPACK (sham injection) | Sham comparator | Procedure: Adductor Canal Block (ACB) + iPACK Block (sham injection)Group B : 25 patients will receive Adductor canal block only under ultrasound guide using 20ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml of saline (sham injection) at the start of the surgery. The patients in Group B will receive ACB and IPACK block (sham injection) as described above. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing total knee replacement.
- ASA physical status I to III
- Sex (males and females).
- Age 20 - 70 years.
Key exclusion criteria (10 listed)
- Patients undergoing bilateral or revision total knee replacement.
- ASA physical status more than III
- Age less than 20 or older than 70
- severe renal insufficiency ( Estimated Glomerular filtration rate eGFR < 15 mL/min/1.73 m2 ).
- history of arrhythmia or seizures.
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 Block (ACB) + iPACK BlockAlso: Adductor Canal Block (ACB), IPACK blockAdductor Canal Block (ACB) in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gaugusing a 22-gauge 100-mm short-bevelled regional block needle. IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration. | Procedure or surgery | Adductor canal block (ACB) + IPACK block |
| Adductor Canal Block (ACB) + iPACK Block (sham injection)Also: Adductor Canal Block, IPACK Block (sham injection)All patients will receive Adductor Canal Block in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gauge 100-mm short-bevelled regional block needle IPACK block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of normal saline will be injected after negative aspiration. | Procedure or surgery | Adductor Canal Block (ACB) + IPACK (sham injection) |
Primary outcome
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.
Time frame: At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery
Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.
3 secondary outcomes
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively
Time frame: Postoperative Pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperative.
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively
Time frame: Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.
The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.
Time frame: Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Rana Magdy, Master contact
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block (ACB) + iPACK Block in people with Adductor Canal Block and Total Knee Replacement Surgery, run by Ain Shams University.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana Magdy, Master, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement. (time frame: At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery). 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 31 Jul 2025.