Knee ArthropathyPhase 4IPACKNCT03094663
Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)
A Phase 4 study testing Bupivacaine with epinephrine, Methylprednisolone and Cefazolin in people with Knee Arthropathy, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Bupivacaine with epinephrine, Methylprednisolone and Cefazolin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 1 Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
- Patients of participating surgeons
Who cannot join
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
- Diabetes
Show all 10Show fewer
- ASA of IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
- Patients with severe valgus deformity and flexion contracture
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital For Special Surgery
New York, New York, 10021
About this study
Official title: Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Read the detailed description
Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.
The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.
Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.
- Conditions
- Knee Arthropathy
- Being tested
- Bupivacaine with epinephrine, Methylprednisolone, Cefazolin, 8 MHz. Chiba needle, Bupivacaine with Dexamethasone
- Keywords
- IPACK, PAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with epinephrineDrug
Also called Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)
bupivacaine 0.5% with epinephrine 30cc
Also called Depo-Medrol, Solu-Medrol, Medrol
40 mg/ml, 1 ml
CefazolinDrug
Also called cephalosporin antibiotics
500 mg in 10 ml
8 MHz. Chiba needleDevice
22G/ 4 inches
Bupivacaine with DexamethasoneDrug
Also called dexamethasone to non-liposomal bupivacaine
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
Bupivacaine 25ccDrug
Also called Exparel, Marcaine, Marcaine Spinal (PF)
25 cc 0.25% bupivacaine
Bupivacaine 20ccDrug
Also called Exparel, Marcaine, Marcaine Spinal (PF)
20cc 0.25% bupivacaine
DexamethasoneDrug
Also called Ozurdex, Maxidex, DexPak 6 Day
2 mg IV dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Peri-Articular Injections only | Active comparator | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
1. Injection prior to cementation
1. bupivacaine 0.5% with epinephrine 30cc;
2. methylprednisolone, 40 mg/ml, 1 ml
3. cefazolin, 500 mg in 10 ml
4. normal saline, 22cc
2. Superficial injection prior to closure.
1. 20cc 0.25% bupivacaine
2. 2 mg IV dexamethasone. Receives: Drug: Bupivacaine with epinephrine; Drug: Methylprednisolone; Drug: Cefazolin; Device: 8 MHz. Chiba needle; Drug: Bupivacaine 25cc; Drug: Bupivacaine 20cc; Drug: Dexamethasone |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Experimental | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
1. Injection prior to cementation
1. bupivacaine 0.25% with epinephrine 30cc;
2. methylprednisolone, 40 mg/ml, 1 ml
3. cefazolin, 500 mg in 10 ml
4. normal saline, 22cc
2. Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine
3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine Receives: Drug: Bupivacaine with epinephrine; Drug: Methylprednisolone; Drug: Cefazolin; Device: 8 MHz. Chiba needle; Drug: Bupivacaine with Dexamethasone; Drug: Bupivacaine 25cc; Drug: Bupivacaine 20cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Pain Scores
Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration.
Min = 0, no pain Max = 10, worst imaginable pain
Measured: 24 hours post block administration
Secondary outcomes (8)
Opioid Consumption
Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported.
Measured: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement
Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain
Despite being collected at various times, the average pain score across all time points was calculated and reported.
Measured: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Ambulation Distance During Physical Therapy
The distance patients were able to walked during physical therapy ambulation. Measured in feet.
The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed.
Measured: It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Level of Patient Satisfaction With Postoperative Pain Management
Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied.
Measured: Post-Operative Day 2
Pain Outcomes
The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question:
0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely
Although measured across different timepoints, the average score of all participants was calculated and reported.
Measured: Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported
Hospital Length of Stay
The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged.
The average length of stay for all patients (reported in minutes) will be reported.
Measured: Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3
Opioid Related Symptom Distress Scale (ORSDS)
ORSDS scores. A lower score is a better outcome. range is 0 to 4.
Measured: Post-Operative Day 1 and Post-Operative Day 2
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome.
The average score for each time point is reported for each arm.
Measured: Measured at pre-operation (day of surgery) and 6 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start28 Feb 2017
- Primary completion31 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David H Kim, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094663
- Sponsor's protocol ID
- 2016-0168
- Acronym
- IPACK
- Status last verified
- Dec 2024
- First submitted
- 21 Feb 2017
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
PubMed 30234517
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03094663
- Acronym / sponsor ID
- IPACK / 2016-0168
- Conditions
- Knee Arthropathy
- Keywords
- IPACK, PAI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Detailed description
Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.
The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.
Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-Articular Injections only | Active comparator | Drug: Bupivacaine with epinephrine, Drug: Methylprednisolone, Drug: Cefazolin, Device: 8 MHz. Chiba needle, Drug: Bupivacaine 25cc, Drug: Bupivacaine 20cc, Drug: DexamethasoneCombined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Experimental | Drug: Bupivacaine with epinephrine, Drug: Methylprednisolone, Drug: Cefazolin, Device: 8 MHz. Chiba needle, Drug: Bupivacaine with Dexamethasone, Drug: Bupivacaine 25cc, Drug: Bupivacaine 20ccCombined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
Key exclusion criteria (10 listed)
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
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 |
|---|---|---|
| Bupivacaine with epinephrineAlso: Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)bupivacaine 0.5% with epinephrine 30cc | Drug | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| MethylprednisoloneAlso: Depo-Medrol, Solu-Medrol, Medrol40 mg/ml, 1 ml | Drug | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| CefazolinAlso: cephalosporin antibiotics500 mg in 10 ml | Drug | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| 8 MHz. Chiba needle22G/ 4 inches | Device | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| Bupivacaine with DexamethasoneAlso: dexamethasone to non-liposomal bupivacaine15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone | Drug | Peri-Articular Injections, Adductor Canal Block, and IPACK |
| Bupivacaine 25ccAlso: Exparel, Marcaine, Marcaine Spinal (PF)25 cc 0.25% bupivacaine | Drug | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| Bupivacaine 20ccAlso: Exparel, Marcaine, Marcaine Spinal (PF)20cc 0.25% bupivacaine | Drug | Peri-Articular Injections only, Peri-Articular Injections, Adductor Canal Block, and IPACK |
| DexamethasoneAlso: Ozurdex, Maxidex, DexPak 6 Day2 mg IV dexamethasone. | Drug | Peri-Articular Injections only |
Primary outcome
Numeric Rating Scale (NRS) Pain Scores
Time frame: 24 hours post block administration
Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain
8 secondary outcomes
Opioid Consumption
Time frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement
Time frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Ambulation Distance During Physical Therapy
Time frame: It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Level of Patient Satisfaction With Postoperative Pain Management
Time frame: Post-Operative Day 2
Pain Outcomes
Time frame: Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported
Hospital Length of Stay
Time frame: Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3
Opioid Related Symptom Distress Scale (ORSDS)
Time frame: Post-Operative Day 1 and Post-Operative Day 2
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Time frame: Measured at pre-operation (day of surgery) and 6 weeks post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30234517Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
- 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.
David H Kim, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine with epinephrine, Methylprednisolone and Cefazolin in people with Knee Arthropathy, run by Hospital for Special Surgery, New York at 1 site in United States.
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 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: finished, as of the sponsor's last update on 27 Dec 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numeric Rating Scale (NRS) Pain Scores (time frame: 24 hours post block administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094663, which also lists 1 linked publication.
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 27 Dec 2024.