ACL InjuryPhase 4NCT05498870
iPACK for Post-op Pain Following ACL Reconstruction
A Phase 4 study testing Adductor Canal Block (ACB) Only and Adductor Canal Block (ACB) + iPACK Block in people with ACL Injury and Post Operative Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- ACL Injury, Post Operative Pain
- What is being tested?
- Adductor Canal Block (ACB) Only and Adductor Canal Block (ACB) + iPACK Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 14 Aug 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years and older
- Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
Who cannot join
- Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
- Patients undergoing hamstring graft or allograft for ACL
- Pre-existing infection at the site of injury
- Patients on chronic opioid treatments
- Pre-existing sensory or motor deficit in operative extremity
- Patients having a revision of previous ACL reconstruction
- Pregnant and/or lactating women
- Weighs less than 40kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction
This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
- Conditions
- ACL Injury, Post Operative Pain
- Being tested
- Adductor Canal Block (ACB) Only, Adductor Canal Block (ACB) + iPACK Block
- Keywords
- acl injury, acl repair
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block (ACB) OnlyDrug
Patients will receive an ACB with lidocaine skin wheal
Adductor Canal Block (ACB) + iPACK BlockDrug
Patients will receive an ACB with iPACK block
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block (ACB) Only | Active comparator | Participants randomized to the ACB only group will receive an adductor canal block alone. Receives: Drug: Adductor Canal Block (ACB) Only |
| ACB + iPACK | Active comparator | Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. Receives: Drug: Adductor Canal Block (ACB) + iPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
Measured: 0-72 hours post op
Secondary outcomes (2)
Total Postoperative Opioid Consumption (Total MME)
The secondary endpoints will measure perioperative opioid consumption through postoperative day 2 in 12-hour intervals and converted into morphine milligram equivalents using standard conversions.
Measured: up to 72 hours post-op
Range of Motion (Degrees)
An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements. The scale of range of motion is from 0 - 135 degrees. The higher the score (degrees), the better the outcome.
Measured: up to two months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start25 Aug 2022
- Primary completion3 Jul 2023
- Study completion14 Aug 2023
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 ACL InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carey Brewbaker, Medical University of South Carolina
- Investigators
- Carey Breabaker, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498870
- Sponsor's protocol ID
- Pro00121103
- Status last verified
- Oct 2024
- First submitted
- 27 Jul 2022
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Brewbaker CL, Moran TE, Wolla CD, Pullen WM, Wolf BJ, Pillow CF, Slone HS. Functional and Analgesic Effects of iPACK Blocks Added to Continuous Adductor Canal Blocks for ACL Reconstruction With Quadriceps Tendon Autograft: A Randomized Controlled Trial. Orthop J Sports Med. 2026 Jul 14;14(7):23259671261445908. doi: 10.1177/23259671261445908. eCollection 2026 Jul.
PubMed 42459597
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT05498870
- Acronym / sponsor ID
- Pro00121103
- Conditions
- ACL Injury, Post Operative Pain
- Keywords
- acl injury, acl repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Posted 10 Jul 2024
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 consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block (ACB) Only | Active comparator | Drug: Adductor Canal Block (ACB) OnlyParticipants randomized to the ACB only group will receive an adductor canal block alone. |
| ACB + iPACK | Active comparator | Drug: Adductor Canal Block (ACB) + iPACK BlockParticipants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 12 years and older
- Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
Key exclusion criteria (8 listed)
- Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
- Patients undergoing hamstring graft or allograft for ACL
- Pre-existing infection at the site of injury
- Patients on chronic opioid treatments
- Pre-existing sensory or motor deficit in operative extremity
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 Block (ACB) OnlyPatients will receive an ACB with lidocaine skin wheal | Drug | Adductor Canal Block (ACB) Only |
| Adductor Canal Block (ACB) + iPACK BlockPatients will receive an ACB with iPACK block | Drug | ACB + iPACK |
Primary outcome
Pain Scores
Time frame: 0-72 hours post op
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
2 secondary outcomes
Total Postoperative Opioid Consumption (Total MME)
Time frame: up to 72 hours post-op
Range of Motion (Degrees)
Time frame: up to two months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42459597Brewbaker CL, Moran TE, Wolla CD, Pullen WM, Wolf BJ, Pillow CF, Slone HS. Functional and Analgesic Effects of iPACK Blocks Added to Continuous Adductor Canal Blocks for ACL Reconstruction With Quadriceps Tendon Autograft: A Randomized Controlled Trial. Orthop J Sports Med. 2026 Jul 14;14(7):23259671261445908. doi: 10.1177/23259671261445908. eCollection 2026 Jul.
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
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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.
Carey Breabaker, MD principal investigator
Medical University of South Carolina
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 Adductor Canal Block (ACB) Only and Adductor Canal Block (ACB) + iPACK Block in people with ACL Injury and Post Operative Pain, run by Medical University of South Carolina 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 2 inclusion and 8 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 16 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 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 10 Jul 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?
Pain Scores (time frame: 0-72 hours post op). 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 NCT05498870, 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 16 Oct 2024.