Postoperative PainIPACKNCT06888349
The Effect of Combined IPACK Block with ACB Versus ACB Alone on Pain Management and Early Mobility After Total Knee Arthroplasty
A study testing spinal anesthesia, Adductor Canal Block and interspace between Popliteal artery and capsule of knee (IPACK) block in people with Postoperative Pain and Motor Activity, run by Ain Shams University at 1 site in Egypt.
Trial summary
This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone . Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Motor Activity
- What is being tested?
- spinal anesthesia, Adductor Canal Block and interspace between Popliteal artery and capsule of knee (IPACK) block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2023to 8 Feb 2024
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Patients of either sex
- Age: between 45 and 75 years.
- Physical status: ASA I- III.
- Weight: BMI between 28-40 kg/m2.
- Lesion: any patient with knee pathology requiring total knee arthroplasty (TKA)
Who cannot join
- o Body mass index >40 kg/m2.
- ASA>III.
- Patient's refusal.
- Revision knee arthroplasty
- Bilateral knee arthroplasty.
- Lack of mental ability to provide informed consent.
- Neuropathic pain or sensory disorders of the surgical limb.
- Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined IPACK(Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block with Adductor Canal Block Versus Adductor Canal Block Alone on Pain Management and Early Mobility After Total Knee Arthroplasty
This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .
Read the detailed description
This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .All patients were subjected to full history taking including current medications and thorough physical examination.
Age, sex, BMI and ASA physical status were recorded and Preoperative investigations were done to all patients including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and activated partial thromboplastin time) and other investigations according to the patient's medical condition. The patients were fasting for 2 to 8 hours preoperatively. All patients were consented with a written consent for the spinal anesthesia and either of the peripheral regional blocks that were held after explaining the procedure. Intraoperatively, All patients were monitored by pulse oximeter, non-invasive blood pressure cuff and electrocardiogram for heart rate and rhythm. IV Access was applied. All patients received 0.03 mg/kg midazolam iv, granisetron 1mg iv and dexamethasone 10 mg iv as a prophylaxis against nausea and vomiting.Sign IN and Time OUT checklist were revised before starting the anesthetic procedure and the surgical procedure, respectively.All patients received spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.All patients received Intraoperative fluids and sedation with intravenous dexmedetomidine if needed.Checking on the availability of intralipid (lipid emulsion 20%) nearby and preparation of the ultrasound device (investigators used in the recent study the Sonosite M-Turbo C Portable Ultrasound). After patients' stabilization, Patients were divided into 2 group.
Group A: received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.
Group B: received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Postoperatively,All patients were transferred to the post anesthesia care unit (PACU).
All patients were monitored at (PACU) for oxygen saturation, heart rate and blood pressure for 2hours observational period.The two groups of patients were evaluated and compared as regard:
Degree of postoperative pain using Numerical Rating Scale (NRS) at the first 48 hrs. The first need for analgesic rescue (NRS score ≥ 4 [0: no pain 10: very severe pain]) at 2, 4, 6, 8, 12, 24, and 48 hr. and the total amount of analgesic rescues was determined. Analgesic rescue was provided using 1 gram paracetamol IV and 30mg ketorolac IV, while in a few cases titration of pethidine was used after failure of the determined analgesic rescue with paracetamol and ketorolac to provide pain relief.
The recovery of spinal motor blockade and early motor ability using Bromage score and the incidence of peroneal motor weakness (dorsiflexion of the ankle and toes).
Length of hospital stays (defined as the days from the end of surgery until discharge).
The first mobilization time recorded in hours. The Timed Up and Go (TUG)test (measured in seconds).This test was performed on the 1st and 2nd postoperative days.Postoperative 1st and 2nd-day Rang of Movement (ROM) measurements.
- Conditions
- Postoperative Pain, Motor Activity
- Being tested
- spinal anesthesia, Adductor Canal Block, interspace between Popliteal artery and capsule of knee (IPACK) block
- Keywords
- Postoperative pain, Early rehabilitation
- Medical subject headings
- Pain, Postoperative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.
Adductor Canal BlockProcedure or surgery
local anesthetic spread around the saphenous nerve in the adductor canal ultrasound guided using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.
interspace between Popliteal artery and capsule of knee (IPACK) blockProcedure or surgery
ultrasound guided Local anesthetic infiltration over the posterior aspect of the femur underneath the popliteal artery targeting the genicular nerves which are the articular branches of tibial and common peroneal nerves, posterior branches of the obturator nerve, and medial genicular nerve using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block (ACB) alone | Active comparator | received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Receives: Procedure: spinal anesthesia; Procedure: Adductor Canal Block |
| adductor canal block (ACB)in addition to (IPACK) block | Active comparator | received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Receives: Procedure: spinal anesthesia; Procedure: Adductor Canal Block; Procedure: interspace between Popliteal artery and capsule of knee (IPACK) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain degree
two groups of patients were evaluated and compared as regard the Degree of postoperative pain using Numerical Rating Scale (NRS) which consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" and 10 being "the worst pain imaginable.", So that the higher the number the worse is the pain . The numerical rating scale is recorded each 4hours at the first 48 hours.
Measured: 48hours
The first time to need analgesic rescue .
The first time to need analgesic rescue when (Numerical rating scale score
≥ 4 which means moderate to severe pain ) is recorded in hours (the Numerical rating scale consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" 1to3 being "mild pain,4to6 being "moderate pain "and 7to10 being "sever pain" . So that the higher the number the worse is the pain.
Measured: 2days
the total amount of analgesic rescues needed measured in numbers
Number of analgesic rescues needed when patient's pain is moderate to sever
Measured: 2days
Secondary outcomes (7)
Sex influence on degree of pain
Two groups were compared as regard number of males and females in each group
Measured: At the time of patients' enrollment in the study.
Age
The ages of patients in each group were recoded and compared .
Measured: At the time of patients' enrollment in the study.
BMI(kg/m2)
BMI of each patient was recorded and the two groups were compared .
Measured: At the time of patients'enrollment in the study.
Motor recovery
Motor recovery after spinal anesthesia blockade Determined by Bromage score done using clinical assessment of motor ability . Bromage a score is score of four levels where score 1 = free movement of legs and feet; score 2 = just able to flex knees with free movement of feet; score 3 = unable to flex knees, but with free movement of feet; and score 4 = unable to move legs or feet.so that score 4 means no motor recovery with complete motor blockade and a(the minimum value) and score 1 means complete motor recovery with no blockade (the maximum value)
Measured: 2days
Mobility recovery
Timed up and go test is done for each patient assessing the ability and the time it takes the patient to move up from a chair and wake for three meters then get back to the chair and is recorded in seconds .
Measured: 2days
Degree of motor recovery
Range of motion test is done for each patient assessing the extension and flexion ability of the knee with measuring and recording the degree of angle in between .
Measured: 2days
Fast recovery and early hospital discharge
Duration of hospital stay is recorded in hours for each patient , so that the patient with hospital stay duration beyond 48hours is considered of delayed rehabilitation and prolonged hospital stay .
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start23 Jan 2023
- Primary completion8 Jan 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Alaa El Deen Mahmoud Abass, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888349
- Sponsor's protocol ID
- FMASU MD 19/2023
- Acronym
- IPACK
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined IPACK(Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block with Adductor Canal Block Versus Adductor Canal Block Alone on Pain Management and Early Mobility After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06888349
- Acronym / sponsor ID
- IPACK / FMASU MD 19/2023
- Conditions
- Postoperative Pain, Motor Activity
- Keywords
- Postoperative pain, Early rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 21 Mar 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.
This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .
Detailed description
This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .All patients were subjected to full history taking including current medications and thorough physical examination.
Age, sex, BMI and ASA physical status were recorded and Preoperative investigations were done to all patients including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and activated partial thromboplastin time) and other investigations according to the patient's medical condition. The patients were fasting for 2 to 8 hours preoperatively. All patients were consented with a written consent for the spinal anesthesia and either of the peripheral regional blocks that were held after explaining the procedure. Intraoperatively, All patients were monitored by pulse oximeter, non-invasive blood pressure cuff and electrocardiogram for heart rate and rhythm. IV Access was applied. All patients received 0.03 mg/kg midazolam iv, granisetron 1mg iv and dexamethasone 10 mg iv as a prophylaxis against nausea and vomiting.Sign IN and Time OUT checklist were revised before starting the anesthetic procedure and the surgical procedure, respectively.All patients received spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.All patients received Intraoperative fluids and sedation with intravenous dexmedetomidine if needed.Checking on the availability of intralipid (lipid emulsion 20%) nearby and preparation of the ultrasound device (investigators used in the recent study the Sonosite M-Turbo C Portable Ultrasound). After patients' stabilization, Patients were divided into 2 group.
Group A: received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.
Group B: received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Postoperatively,All patients were transferred to the post anesthesia care unit (PACU).
All patients were monitored at (PACU) for oxygen saturation, heart rate and blood pressure for 2hours observational period.The two groups of patients were evaluated and compared as regard:
Degree of postoperative pain using Numerical Rating Scale (NRS) at the first 48 hrs. The first need for analgesic rescue (NRS score ≥ 4 [0: no pain 10: very severe pain]) at 2, 4, 6, 8, 12, 24, and 48 hr. and the total amount of analgesic rescues was determined. Analgesic rescue was provided using 1 gram paracetamol IV and 30mg ketorolac IV, while in a few cases titration of pethidine was used after failure of the determined analgesic rescue with paracetamol and ketorolac to provide pain relief.
The recovery of spinal motor blockade and early motor ability using Bromage score and the incidence of peroneal motor weakness (dorsiflexion of the ankle and toes).
Length of hospital stays (defined as the days from the end of surgery until discharge).
The first mobilization time recorded in hours. The Timed Up and Go (TUG)test (measured in seconds).This test was performed on the 1st and 2nd postoperative days.Postoperative 1st and 2nd-day Rang of Movement (ROM) measurements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block (ACB) alone | Active comparator | Procedure: spinal anesthesia, Procedure: Adductor Canal Blockreceived ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. |
| adductor canal block (ACB)in addition to (IPACK) block | Active comparator | Procedure: spinal anesthesia, Procedure: Adductor Canal Block, Procedure: interspace between Popliteal artery and capsule of knee (IPACK) blockreceived ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: Patients of either sex
- Age: between 45 and 75 years.
- Physical status: ASA I- III.
- Weight: BMI between 28-40 kg/m2.
- Lesion: any patient with knee pathology requiring total knee arthroplasty (TKA)
Key exclusion criteria (8 listed)
- o Body mass index >40 kg/m2.
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 |
|---|---|---|
| spinal anesthesiaspinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space. | Procedure or surgery | adductor canal block (ACB) alone, adductor canal block (ACB)in addition to (IPACK) block |
| Adductor Canal Blocklocal anesthetic spread around the saphenous nerve in the adductor canal ultrasound guided using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. | Procedure or surgery | adductor canal block (ACB) alone, adductor canal block (ACB)in addition to (IPACK) block |
| interspace between Popliteal artery and capsule of knee (IPACK) blockultrasound guided Local anesthetic infiltration over the posterior aspect of the femur underneath the popliteal artery targeting the genicular nerves which are the articular branches of tibial and common peroneal nerves, posterior branches of the obturator nerve, and medial genicular nerve using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. | Procedure or surgery | adductor canal block (ACB)in addition to (IPACK) block |
Primary outcome
postoperative pain degree
Time frame: 48hours
two groups of patients were evaluated and compared as regard the Degree of postoperative pain using Numerical Rating Scale (NRS) which consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" and 10 being "the worst pain imaginable.", So that the higher the number the worse is the pain . The numerical rating scale is recorded each 4hours at the first 48 hours.
The first time to need analgesic rescue .
Time frame: 2days
The first time to need analgesic rescue when (Numerical rating scale score ≥ 4 which means moderate to severe pain ) is recorded in hours (the Numerical rating scale consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" 1to3 being "mild pain,4to6 being "moderate pain "and 7to10 being "sever pain" . So that the higher the number the worse is the pain.
the total amount of analgesic rescues needed measured in numbers
Time frame: 2days
Number of analgesic rescues needed when patient's pain is moderate to sever
7 secondary outcomes
Sex influence on degree of pain
Time frame: At the time of patients' enrollment in the study.
Age
Time frame: At the time of patients' enrollment in the study.
BMI(kg/m2)
Time frame: At the time of patients'enrollment in the study.
Motor recovery
Time frame: 2days
Mobility recovery
Time frame: 2days
Degree of motor recovery
Time frame: 2days
Fast recovery and early hospital discharge
Time frame: 48hours
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 21 Mar 2025.
- 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 spinal anesthesia, Adductor Canal Block and interspace between Popliteal artery and capsule of knee (IPACK) block in people with Postoperative Pain and Motor Activity, 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 5 inclusion and 8 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 21 Mar 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.
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?
postoperative pain degree (time frame: 48hours). The study lists 3 primary outcomes in all. 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 21 Mar 2025.