Knee OsteoarthritisNCT07288970
ACB With S-ESPB Versus ACB With iPACK for Knee Arthroplasty
A study testing Adductor Canal Block, Sacral Erector Spinae Plane Block and iPACK Block in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Adductor Canal Block, Sacral Erector Spinae Plane Block and iPACK Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 25 Dec 2025to 4 Oct 2026
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Scheduled for elective unilateral total knee arthroplasty under spinal or general anesthesia
- ASA physical status I-III
- Planned use of regional anesthesia with an adductor canal block as part of multimodal analgesia
- Ability to communicate pain intensity using the NRS scale
- Written informed consent obtained from the patient
Who cannot join
- Refusal or inability to provide informed consent
- Allergy, intolerance, or contraindication to local anesthetics (ropivacaine)
- Pre-existing significant neurological deficit or neuropathy in the operative limb
- Coagulopathy or anticoagulation that contraindicates peripheral nerve blocks (e.g., INR >1.5, platelets <100,000/µL, or therapeutic anticoagulation that cannot be safely paused)
- Infection at or near the planned needle insertion sites
- Severe hepatic or renal impairment
Show all 11Show fewer
- Chronic opioid therapy (>30 days of daily opioid use before surgery)
- Cognitive impairment or delirium preventing reliable pain assessment BMI > 40 kg/m² (optional - if chcesz ograniczyć ze względu na trudność USG)
- Previous knee arthroplasty on the same side or revision TKA (jeśli chcesz tylko primary TKA)
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adductor Canal Block Combined With Sacral Erector Spinae Plane Block Versus Adductor Canal Block Combined With iPACK Block in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Tria
This study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. The ACB is then combined with either a sacral erector spinae plane block (S-ESPB) or an iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block to improve posterior knee analgesia.
All patients will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of two groups:
Read more
Group 1: ACB combined with a sacral erector spinae plane block (S-ESPB) using 20 mL of 0.2% ropivacaine.
Group 2: ACB combined with an iPACK block using 20 mL of 0.2% ropivacaine. Both techniques aim to provide effective postoperative analgesia while minimizing motor blockade and allowing for early mobilization. It is not known whether combining ACB with S-ESPB or with iPACK provides superior pain control, reduces opioid requirements, or results in better functional recovery after total knee arthroplasty.
The main purpose of this study is to compare the time to first rescue analgesia and overall postoperative pain control between the two regional anesthesia strategies. The study will also evaluate opioid consumption, motor function, functional mobility, side effects, and block-related complications.
We hypothesize that both combinations will provide effective analgesia, but their impact on pain intensity, duration of analgesia, and functional recovery may differ.
Read the detailed description
Total knee arthroplasty (TKA) is associated with significant postoperative pain, which can limit early mobilization, delay rehabilitation, and increase opioid use. Inadequate pain control may lead to complications such as decreased range of motion, prolonged hospitalization, and reduced patient satisfaction. Regional anesthesia techniques are a cornerstone of multimodal analgesia protocols for TKA.
The adductor canal block (ACB) is a motor-sparing technique that targets the saphenous nerve and nerve to vastus medialis while largely preserving quadriceps strength. However, ACB alone may not provide sufficient analgesia for posterior knee structures. To address this limitation, it is often combined with other blocks that target posterior knee innervation.
The iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block is designed to anesthetize the articular branches supplying the posterior capsule of the knee without causing significant motor block. The sacral erector spinae plane block (S-ESPB) is a more proximal truncal block, which may provide analgesia to the posterior knee and surrounding structures through spread of local anesthetic in the fascial planes.
This randomized controlled trial will compare two regional anesthesia strategies in patients undergoing total knee arthroplasty:
Adductor canal block (ACB) combined with sacral erector spinae plane block (S-ESPB).
Adductor canal block (ACB) combined with iPACK block. In both groups, 20 mL of 0.2% ropivacaine will be used for each block (ACB + S-ESPB or ACB + iPACK). All patients will receive standard perioperative care and multimodal analgesia according to institutional protocols.
The primary outcome of the study is the time to first rescue analgesia within 48 hours after surgery. Secondary outcomes include pain intensity at rest and during movement, total opioid consumption, motor function (quadriceps strength), postoperative nausea and vomiting, hemodynamic events, block-related complications, time to first mobilization, and patient satisfaction with pain management.
The study aims to determine whether combining ACB with S-ESPB or with iPACK results in better analgesia and functional outcomes after TKA. The results may help optimize regional anesthesia protocols for total knee arthroplasty and improve postoperative recovery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Adductor Canal Block, Sacral Erector Spinae Plane Block, iPACK Block
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
Also called ACB
Ultrasound-guided adductor canal block performed with 20 mL of 0.2% ropivacaine injected around the saphenous nerve within the adductor canal. Used in both study arms as part of the regional anesthesia protocol for total knee arthroplasty.
Sacral Erector Spinae Plane BlockProcedure or surgery
Also called S-ESPB; Sacral ESP block
Ultrasound-guided sacral erector spinae plane block performed with 20 mL of 0.2% ropivacaine injected deep to the erector spinae muscle at the sacral level. Used in combination with ACB in the ACB + S-ESPB group.
iPACK BlockProcedure or surgery
Also called Infiltration between the popliteal artery and the posterior capsule of the knee
Ultrasound-guided iPACK block performed with 20 mL of 0.2% ropivacaine injected between the popliteal artery and the posterior capsule of the knee. Used in combination with ACB in the ACB + iPACK group.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB) | Active comparator | Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and a sacral erector spinae plane block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia. Receives: Procedure: Adductor Canal Block; Procedure: Sacral Erector Spinae Plane Block |
| Adductor Canal Block Plus iPACK Block (ACB + iPACK) | Active comparator | Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and an iPACK block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia. 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.
Time to First Rescue Analgesia
Time (in hours) from completion of the regional blocks to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).
Measured: Within 48 hours after surgery.
Secondary outcomes (19)
Pain Intensity at Rest (NRS 0-10)
Pain at rest measured using the 0-10 NRS (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups.
Measured: 4 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Pain at rest measured using the 0-10 NRS (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups.
Measured: 8 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Pain at rest measured using the 0-10 NRS (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups.
Measured: 12 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Pain at rest measured using the 0-10 NRS (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups.
Measured: 24 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Pain at rest measured using the 0-10 NRS (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups.
Measured: 48 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Pain during standardized knee movement (e.g., flexion or assisted mobilization) measured using the 0-10 NRS.
Measured: 4 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Pain during standardized knee movement (e.g., flexion or assisted mobilization) measured using the 0-10 NRS.
Measured: 8 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Pain during standardized knee movement (e.g., flexion or assisted mobilization) measured using the 0-10 NRS.
Measured: 12 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Pain during standardized knee movement (e.g., flexion or assisted mobilization) measured using the 0-10 NRS.
Measured: 24 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Pain during standardized knee movement (e.g., flexion or assisted mobilization) measured using the 0-10 NRS.
Measured: 48 hours after surgery.
Total Opioid Consumption
Cumulative dose of opioids converted to oral morphine milligram equivalents (MME).
Measured: 0-48 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Quadriceps muscle strength assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the regional anesthesia techniques.
Measured: 4 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Quadriceps muscle strength assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the regional anesthesia techniques.
Measured: 8 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Quadriceps muscle strength assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the regional anesthesia techniques.
Measured: 12 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Quadriceps muscle strength assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the regional anesthesia techniques.
Measured: 24 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Quadriceps muscle strength assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the regional anesthesia techniques.
Measured: 48 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Presence of nausea or vomiting requiring antiemetic therapy. Proportion of patients with at least one episode will be recorded.
Measured: 0-48 hours after surgery.
Hemodynamic Adverse Events
Incidence of hypotension (systolic BP <90 mmHg or >30% decrease from baseline) and bradycardia (HR <50/min) requiring treatment.
Measured: From block placement until 24 hours after surgery.
Block-Related Adverse Events
Incidence of complications related to the regional blocks, including prolonged sensory or motor deficit, nerve injury (evaluated in outpatient clinic if required), hematoma, infection at the injection site, persistent weakness, or local anesthetic systemic toxicity.
Measured: From block placement until 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start25 Dec 2025
- Primary completion4 Sep 2026
- Study completion4 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288970
- Sponsor's protocol ID
- 11/2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Canal Block Combined With Sacral Erector Spinae Plane Block Versus Adductor Canal Block Combined With iPACK Block in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Tria
- ClinicalTrials.gov ID
- NCT07288970
- Acronym / sponsor ID
- 11/2025
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Oct 2026 (actual)
- First posted
- 17 Dec 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 study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. The ACB is then combined with either a sacral erector spinae plane block (S-ESPB) or an iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block to improve posterior knee analgesia.
All patients will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of two groups:
Group 1: ACB combined with a sacral erector spinae plane block (S-ESPB) using 20 mL of 0.2% ropivacaine.
Group 2: ACB combined with an iPACK block using 20 mL of 0.2% ropivacaine. Both techniques aim to provide effective postoperative analgesia while minimizing motor blockade and allowing for early mobilization. It is not known whether combining ACB with S-ESPB or with iPACK provides superior pain control, reduces opioid requirements, or results in better functional recovery after total knee arthroplasty.
The main purpose of this study is to compare the time to first rescue analgesia and overall postoperative pain control between the two regional anesthesia strategies. The study will also evaluate opioid consumption, motor function, functional mobility, side effects, and block-related complications.
We hypothesize that both combinations will provide effective analgesia, but their impact on pain intensity, duration of analgesia, and functional recovery may differ.
Detailed description
Total knee arthroplasty (TKA) is associated with significant postoperative pain, which can limit early mobilization, delay rehabilitation, and increase opioid use. Inadequate pain control may lead to complications such as decreased range of motion, prolonged hospitalization, and reduced patient satisfaction. Regional anesthesia techniques are a cornerstone of multimodal analgesia protocols for TKA.
The adductor canal block (ACB) is a motor-sparing technique that targets the saphenous nerve and nerve to vastus medialis while largely preserving quadriceps strength. However, ACB alone may not provide sufficient analgesia for posterior knee structures. To address this limitation, it is often combined with other blocks that target posterior knee innervation.
The iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block is designed to anesthetize the articular branches supplying the posterior capsule of the knee without causing significant motor block. The sacral erector spinae plane block (S-ESPB) is a more proximal truncal block, which may provide analgesia to the posterior knee and surrounding structures through spread of local anesthetic in the fascial planes.
This randomized controlled trial will compare two regional anesthesia strategies in patients undergoing total knee arthroplasty:
Adductor canal block (ACB) combined with sacral erector spinae plane block (S-ESPB).
Adductor canal block (ACB) combined with iPACK block. In both groups, 20 mL of 0.2% ropivacaine will be used for each block (ACB + S-ESPB or ACB + iPACK). All patients will receive standard perioperative care and multimodal analgesia according to institutional protocols.
The primary outcome of the study is the time to first rescue analgesia within 48 hours after surgery. Secondary outcomes include pain intensity at rest and during movement, total opioid consumption, motor function (quadriceps strength), postoperative nausea and vomiting, hemodynamic events, block-related complications, time to first mobilization, and patient satisfaction with pain management.
The study aims to determine whether combining ACB with S-ESPB or with iPACK results in better analgesia and functional outcomes after TKA. The results may help optimize regional anesthesia protocols for total knee arthroplasty and improve postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB) | Active comparator | Procedure: Adductor Canal Block, Procedure: Sacral Erector Spinae Plane BlockParticipants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and a sacral erector spinae plane block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia. |
| Adductor Canal Block Plus iPACK Block (ACB + iPACK) | Active comparator | Procedure: Adductor Canal Block, Procedure: iPACK BlockParticipants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and an iPACK block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 years or older
- Scheduled for elective unilateral total knee arthroplasty under spinal or general anesthesia
- ASA physical status I-III
- Planned use of regional anesthesia with an adductor canal block as part of multimodal analgesia
- Ability to communicate pain intensity using the NRS scale
Key exclusion criteria (11 listed)
- Refusal or inability to provide informed consent
- Allergy, intolerance, or contraindication to local anesthetics (ropivacaine)
- Pre-existing significant neurological deficit or neuropathy in the operative limb
- Coagulopathy or anticoagulation that contraindicates peripheral nerve blocks (e.g., INR >1.5, platelets <100,000/µL, or therapeutic anticoagulation that cannot be safely paused)
- Infection at or near the planned needle insertion sites
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 BlockAlso: ACBUltrasound-guided adductor canal block performed with 20 mL of 0.2% ropivacaine injected around the saphenous nerve within the adductor canal. Used in both study arms as part of the regional anesthesia protocol for total knee arthroplasty. | Procedure or surgery | Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB), Adductor Canal Block Plus iPACK Block (ACB + iPACK) |
| Sacral Erector Spinae Plane BlockAlso: S-ESPB; Sacral ESP blockUltrasound-guided sacral erector spinae plane block performed with 20 mL of 0.2% ropivacaine injected deep to the erector spinae muscle at the sacral level. Used in combination with ACB in the ACB + S-ESPB group. | Procedure or surgery | Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB) |
| iPACK BlockAlso: Infiltration between the popliteal artery and the posterior capsule of the kneeUltrasound-guided iPACK block performed with 20 mL of 0.2% ropivacaine injected between the popliteal artery and the posterior capsule of the knee. Used in combination with ACB in the ACB + iPACK group. | Procedure or surgery | Adductor Canal Block Plus iPACK Block (ACB + iPACK) |
Primary outcome
Time to First Rescue Analgesia
Time frame: Within 48 hours after surgery.
Time (in hours) from completion of the regional blocks to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).
19 secondary outcomes
Pain Intensity at Rest (NRS 0-10)
Time frame: 4 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Time frame: 8 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Time frame: 12 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Time frame: 24 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Time frame: 48 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Time frame: 4 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Time frame: 8 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Time frame: 12 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Time frame: 24 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Time frame: 48 hours after surgery.
Total Opioid Consumption
Time frame: 0-48 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Time frame: 4 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Time frame: 8 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Time frame: 12 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Time frame: 24 hours after surgery.
Motor Function (Quadriceps Strength, MRC Scale)
Time frame: 48 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 0-48 hours after surgery.
Hemodynamic Adverse Events
Time frame: From block placement until 24 hours after surgery.
Block-Related Adverse Events
Time frame: From block placement until 30 days after surgery.
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Malgorzata Reysner, MD PhD study chair
Poznan University of Medical Sciences
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, Sacral Erector Spinae Plane Block and iPACK Block in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
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 6 inclusion and 11 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 19 Oct 2026. 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 Poland. 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?
Time to First Rescue Analgesia (time frame: Within 48 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 19 Oct 2026.