Anterior Cruciate Ligament (ACL) TearPAI in ACLRNCT06630520
Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
A study testing Periarticular injection in people with Anterior Cruciate Ligament (ACL) Tear and Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear, Arthroscopic Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Periarticular injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2022to 20 Jun 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.
Who cannot join
- 1) patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.
- Conditions
- Anterior Cruciate Ligament (ACL) Tear, Arthroscopic Anterior Cruciate Ligament Reconstruction
- Being tested
- Periarticular injection
- Keywords
- periarticular injection, morphine consumption, pain control
- Medical subject headings
- Lacerations, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular injectionCombination product
A 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine.
Before wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular injection | Active comparator | Not described Receives: Combination Product: Periarticular injection |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores
Measured: at different time points (postoperative 4,8,24-hour, before discharge) after surgery
Secondary outcomes (1)
cumulative morphine consumption (mg)
Measured: at post-operative 4, 8, 24-hour and before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Mar 2022
- Primary completion20 Jun 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, En-Rung Chiang, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630520
- Sponsor's protocol ID
- 2022-05-004B
- Acronym
- PAI in ACLR
- Status last verified
- Feb 2022
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Concerning the patient\'s privacy
Publications
Ma HH, Chen KH, Chiang ER, Ma HL. Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery. Arthroscopy. 2025 Oct;41(10):4095-4102. doi: 10.1016/j.arthro.2025.03.014. Epub 2025 Mar 12.
PubMed 40086524
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06630520
- Acronym / sponsor ID
- PAI in ACLR / 2022-05-004B
- Conditions
- Anterior Cruciate Ligament (ACL) Tear, Arthroscopic Anterior Cruciate Ligament Reconstruction
- Keywords
- periarticular injection, morphine consumption, pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 8 Oct 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.
In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periarticular injection | Active comparator | Combination Product: Periarticular injection |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.
Key exclusion criteria (1 listed)
- 1) patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.
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 |
|---|---|---|
| Periarticular injectionA 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine. Before wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery. | Combination product | Periarticular injection |
Primary outcome
VAS scores
Time frame: at different time points (postoperative 4,8,24-hour, before discharge) after surgery
1 secondary outcome
cumulative morphine consumption (mg)
Time frame: at post-operative 4, 8, 24-hour and before discharge
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 8 Oct 2024.
- Derived from this study: PubMed 40086524Ma HH, Chen KH, Chiang ER, Ma HL. Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery. Arthroscopy. 2025 Oct;41(10):4095-4102. doi: 10.1016/j.arthro.2025.03.014. Epub 2025 Mar 12.
- Individual participant dataSharing planned: Undecided. Concerning the patient\'s privacy
Related trials for Anterior Cruciate Ligament (ACL) Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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 Periarticular injection in people with Anterior Cruciate Ligament (ACL) Tear and Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 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 8 Oct 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 Taiwan. 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?
VAS scores (time frame: at different time points (postoperative 4,8,24-hour, before discharge) after surgery). 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 NCT06630520, 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 8 Oct 2024.