Pain, AcuteNCT06514365
Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.
A study testing IPACK block with Bupivacaine 0.25% with adrenaline in people with Pain, Acute and Knee Osteoarthritis, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Acute, Knee Osteoarthritis, Anesthesia
- What is being tested?
- IPACK block with Bupivacaine 0.25% with adrenaline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2020to 1 Aug 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
- Locoregional anesthesia
- Age equal to or greater than 18 years
- Consent to participate in the study
Who cannot join
- Age under 18 years old
- General anesthesia
- Allergy to local anesthetics
- Severe kidney failure (Cr ≥ 2mg / dL)
- Chronic opioid use (over 3 months)
- Chronic pregabalin / gabapentin use (more than 3 months)
- Psychiatric illness that may interfere with the evaluation or follow-up
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Madalina Dinu, 0034600349517, madidinu@hotmail.com
About this study
Official title: Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.
There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.
Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.
- Conditions
- Pain, Acute, Knee Osteoarthritis, Anesthesia
- Being tested
- IPACK block with Bupivacaine 0.25% with adrenaline
- Keywords
- Ipack, Block, Total knee replacement
- Medical subject headings
- Acute Pain, Osteoarthritis, Knee, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK block with Bupivacaine 0.25% with adrenalineDrug
Also called Interspace between the Popliteal Artery and the Capsule of the posterior Knee
The iPACK in performed in the popliteal fossa about 1 finger breath above the patella, ecoguided. That aims to anesthetize the articular branches to the posterior aspect of the knee in the popliteal region.
| Study group | Role | What they receive |
|---|---|---|
| Echo-guided IPACK block | Experimental | IPACK block using 0.25% bupivacaine 15mL with adrenaline once. Receives: Drug: IPACK block with Bupivacaine 0.25% with adrenaline |
| Echo-guided sciatic block | Active comparator | Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once. Receives: Drug: IPACK block with Bupivacaine 0.25% with adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest
Measured by the numerical visual scale at 6 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 6 hours after surgery
Pain at rest
Measured by the numerical visual scale at 24 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 24 hours after surgery
Pain at rest
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 48 hours after surgery
Pain at movement
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 6 hours after surgery
Pain with movement
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 24 hours after surgery
Pain with movement
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Measured: 48 hours after surgery
Motor block
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Measured: 6 hours after surgery
Motor block
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Measured: 24 hours after surgery
Motor block
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Measured: 48 hours after surgery
Secondary outcomes (6)
Opioids dose
Measured in milligrams of intravenous morphine hydrochloride daily.
Measured: 6 hours after surgery
Opioids dose
Measured in milligrams of intravenous morphine hydrochloride daily.
Measured: 24 hours after surgery
Opioids dose
Measured in milligrams of intravenous morphine hydrochloride daily.
Measured: 48 hours after surgery
Discharge days
Time to discharge measured in days
Measured: Days
Patient satisfaction
Patient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction.
Measured: 24 hours after surgery
Ambulation time
Time to ambulation (measured in hours) from discharge from URPA
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start10 Jun 2020
- Primary completion1 Jun 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinu, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514365
- Sponsor's protocol ID
- IPACK-20
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2020
- Last updated
- 23 Jul 2024
- Results posted
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06514365
- Acronym / sponsor ID
- IPACK-20
- Conditions
- Pain, Acute, Knee Osteoarthritis, Anesthesia
- Keywords
- Ipack, Block, Total knee replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 23 Jul 2024 (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.
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.
There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.
Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo-guided IPACK block | Experimental | Drug: IPACK block with Bupivacaine 0.25% with adrenalineIPACK block using 0.25% bupivacaine 15mL with adrenaline once. |
| Echo-guided sciatic block | Active comparator | Drug: IPACK block with Bupivacaine 0.25% with adrenalineSciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
- Locoregional anesthesia
- Age equal to or greater than 18 years
- Consent to participate in the study
Key exclusion criteria (7 listed)
- Age under 18 years old
- General anesthesia
- Allergy to local anesthetics
- Severe kidney failure (Cr ≥ 2mg / dL)
- Chronic opioid use (over 3 months)
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 |
|---|---|---|
| IPACK block with Bupivacaine 0.25% with adrenalineAlso: Interspace between the Popliteal Artery and the Capsule of the posterior KneeThe iPACK in performed in the popliteal fossa about 1 finger breath above the patella, ecoguided. That aims to anesthetize the articular branches to the posterior aspect of the knee in the popliteal region. | Drug | Echo-guided IPACK block, Echo-guided sciatic block |
Primary outcome
Pain at rest
Time frame: 6 hours after surgery
Measured by the numerical visual scale at 6 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at rest
Time frame: 24 hours after surgery
Measured by the numerical visual scale at 24 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at rest
Time frame: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at movement
Time frame: 6 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain with movement
Time frame: 24 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain with movement
Time frame: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Motor block
Time frame: 6 hours after surgery
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Motor block
Time frame: 24 hours after surgery
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Motor block
Time frame: 48 hours after surgery
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
6 secondary outcomes
Opioids dose
Time frame: 6 hours after surgery
Opioids dose
Time frame: 24 hours after surgery
Opioids dose
Time frame: 48 hours after surgery
Discharge days
Time frame: Days
Patient satisfaction
Time frame: 24 hours after surgery
Ambulation time
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPACK block with Bupivacaine 0.25% with adrenaline in people with Pain, Acute and Knee Osteoarthritis, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 7 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 23 Jul 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madalina Dinu, Mrs (0034600349517, madidinu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest (time frame: 6 hours after surgery). The study lists 9 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 23 Jul 2024.