Knee ArthropathyNCT04295421
IPACK Block After Total Knee Arthroplasty
A study testing adductor canal block and IPACK block in people with Knee Arthropathy and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy, Postoperative Pain
- What is being tested?
- adductor canal block and IPACK block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTunisia
- Study dates
- 31 Mar 2020to 31 Jul 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary total knee arthroplasty under spinal anesthesia
Who cannot join
- Contraindication or refusal to regional anesthesia
- Contraindication to non steroidal anti inflammatory (NSAID's)
- Allergy to opioids
- Allergy to paracetamol
- Creatinine clearance < 30ml/min
- Weight<50 kg or >100kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty
Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.
Read the detailed description
This is a prospective, randomized and double blinded study
All patients received :
- Pregabalin 150 mg preoperatively 12 h before the surgery.
- Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
- Group 1: IPACK + ACB single shoot
- Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%
Post operative analgesia included:
- Paracetamol 1g IV every 6 hours
- Diclofenac sodium (50mg) 1 tablet x 2 per day
- Pregabalin 150 mg given orally once daily for a period of 4 weeks.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
- Continuous ACB catheter for 48H with : 4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1
- Conditions
- Knee Arthropathy, Postoperative Pain
- Being tested
- adductor canal block, IPACK block
- Keywords
- knee arthoplasty, nerve block, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.
IPACK blockProcedure or surgery
IPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H
| Study group | Role | What they receive |
|---|---|---|
| Canal adductor block | Active comparator | ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%. Receives: Procedure: adductor canal block |
| IPACK block | Experimental | IPACK was realized after spinal anesthesia. Patient was placed in a supine position and knee placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and the needle was inserted from 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 was placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.2% ropivacaine was injected for each side.
A ACB was done postoperatively with 20 ml ropivacaine 0.2% and a catheter was kept for 48H with 4 ml/h saline Receives: Procedure: adductor canal block; Procedure: IPACK block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
total Morphine consumption
Measured: Day 2
Secondary outcomes (5)
Pain score at rest
numerical rating scale [0=no pain ; 10=worste pain]
Measured: Day 2
Pain score during mouvment
numerical rating scale
Measured: Day 2 [0=no pain ; 10=worste pain]
Ambulation distance
number of steps walked by the patient
Measured: Day 2
Chronic pain
DN4 score [0=minimum to 10= worste score]
Measured: Month 6
functional status
KOOS PS score [0=minimum to 28= worste score]
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start31 Mar 2020
- Primary completion30 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
- Investigators
- khaireddine Raddaoui, MD, Principal investigator, Tunis El Manar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295421
- Sponsor's protocol ID
- CE-IMKO 101/2019
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04295421
- Acronym / sponsor ID
- CE-IMKO 101/2019
- Conditions
- Knee Arthropathy, Postoperative Pain
- Keywords
- knee arthoplasty, nerve block, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 4 Mar 2020 (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.
Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.
Detailed description
This is a prospective, randomized and double blinded study
All patients received :
- Pregabalin 150 mg preoperatively 12 h before the surgery.
- Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
- Group 1: IPACK + ACB single shoot
- Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%
Post operative analgesia included:
- Paracetamol 1g IV every 6 hours
- Diclofenac sodium (50mg) 1 tablet x 2 per day
- Pregabalin 150 mg given orally once daily for a period of 4 weeks.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
- Continuous ACB catheter for 48H with : 4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canal adductor block | Active comparator | Procedure: adductor canal blockACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%. |
| IPACK block | Experimental | Procedure: adductor canal block, Procedure: IPACK blockIPACK was realized after spinal anesthesia. Patient was placed in a supine position and knee placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and the needle was inserted from 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 was placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.2% ropivacaine was injected for each side. A ACB was done postoperatively with 20 ml ropivacaine 0.2% and a catheter was kept for 48H with 4 ml/h saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary total knee arthroplasty under spinal anesthesia
Key exclusion criteria (6 listed)
- Contraindication or refusal to regional anesthesia
- Contraindication to non steroidal anti inflammatory (NSAID's)
- Allergy to opioids
- Allergy to paracetamol
- Creatinine clearance < 30ml/min
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 blockACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%. | Procedure or surgery | Canal adductor block, IPACK block |
| IPACK blockIPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H | Procedure or surgery | IPACK block |
Primary outcome
Morphine consumption
Time frame: Day 2
total Morphine consumption
5 secondary outcomes
Pain score at rest
Time frame: Day 2
Pain score during mouvment
Time frame: Day 2 [0=no pain ; 10=worste pain]
Ambulation distance
Time frame: Day 2
Chronic pain
Time frame: Month 6
functional status
Time frame: Month 6
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 13 Feb 2024.
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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.
khaireddine Raddaoui, MD principal investigator
Tunis El Manar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adductor canal block and IPACK block in people with Knee Arthropathy and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
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: finished, as of the sponsor's last update on 13 Feb 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 Tunisia. 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?
Morphine consumption (time frame: Day 2). 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 13 Feb 2024.