Pain, PostoperativePhase 4NCT05985629
IPACK on Early Pain Scores After ACL Reconstruction
A Phase 4 study testing IPACK in people with Pain, Postoperative and Anterior Cruciate Ligament Injuries, run by Loyola University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are: if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain, Postoperative, Anterior Cruciate Ligament Injuries, Analgesics, Opioid
- What is being tested?
- IPACK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 3 Aug 2026
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery.
- Patients 16 and over
- English speaking patients
- Patients who have the capacity to make their own medical decisions and consent to the study
Who cannot join
- Previous surgery on the operative knee
- Previous knee infection
- Chronic opioid use
- Have a known allergy to local anesthetics
- Patient using autograft (cadaver) for ACL reconstruction.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Susan Fargo, BA, CIP, CCRP, 708-216-8046, sfargo@luc.edu
John Miller, MD
About this study
Official title: The Effect of IPACK Nerve Blocks on Early ACL Pain Scores
The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are:
- if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery
- if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery.
Read more
Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to.
Researchers will compare self-reported pain scores and short-term opioid use of all study participants.
Read the detailed description
Eligible patients will be approached for voluntary study participation after they have made the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola University Department of Orthopedic Surgery for management of their ACL tear.
The study design is a double-blind, randomized trial. Patients will be randomly selected to the control group or the treatment group. The groups will be randomized 1:1 using a block method to be implemented. The control group will receive a sham block, while the treatment group will receive the IPACK block. The use of a sham block, administered by the anesthesia team, is to ensure that Dr. Miller is blinded to patient's treatment group. After administration of the block and a completed ACL reconstruction surgery, pain scores will be collected from the patient at two time points. First, pain scores will be collected in the post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon waking up, one hour after waking up and upon discharge. Second, pain scores will be collected during the standard post-operative follow-up phone call that Dr. Miller makes with all his patients one day after surgery using the VAS pain scale. Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery using a simple questionnaire
- Being tested
- IPACK, PLACEBO
- Medical subject headings
- Pain, Postoperative, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACKDrug
Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.
PLACEBODrug
The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.
| Study group | Role | What they receive |
|---|---|---|
| IPACK | Experimental | After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected. Receives: Drug: IPACK |
| Placebo | Placebo comparator | After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected. Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.
Measured: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery
Opioid Consumption
Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.
Measured: 2-3 hours after surgery; 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Aug 2023
- Primary completion3 Aug 2025 (estimated)
- Study completion3 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985629
- Sponsor's protocol ID
- LU 216180
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not have intentions on sharing IPD with other researchers at this time. If we decide to collaborate in the future, IPD will be de-identified prior to sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IPACK Nerve Blocks on Early ACL Pain Scores
- ClinicalTrials.gov ID
- NCT05985629
- Acronym / sponsor ID
- LU 216180
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 3 Aug 2025 (estimated)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are:
- if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery
- if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery.
Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to.
Researchers will compare self-reported pain scores and short-term opioid use of all study participants.
Detailed description
Eligible patients will be approached for voluntary study participation after they have made the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola University Department of Orthopedic Surgery for management of their ACL tear.
The study design is a double-blind, randomized trial. Patients will be randomly selected to the control group or the treatment group. The groups will be randomized 1:1 using a block method to be implemented. The control group will receive a sham block, while the treatment group will receive the IPACK block. The use of a sham block, administered by the anesthesia team, is to ensure that Dr. Miller is blinded to patient's treatment group. After administration of the block and a completed ACL reconstruction surgery, pain scores will be collected from the patient at two time points. First, pain scores will be collected in the post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon waking up, one hour after waking up and upon discharge. Second, pain scores will be collected during the standard post-operative follow-up phone call that Dr. Miller makes with all his patients one day after surgery using the VAS pain scale. Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery using a simple questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPACK | Experimental | Drug: IPACKAfter the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected. |
| Placebo | Placebo comparator | Drug: PLACEBOAfter the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery.
- Patients 16 and over
- English speaking patients
- Patients who have the capacity to make their own medical decisions and consent to the study
Key exclusion criteria (5 listed)
- Previous surgery on the operative knee
- Previous knee infection
- Chronic opioid use
- Have a known allergy to local anesthetics
- Patient using autograft (cadaver) for ACL reconstruction.
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 |
|---|---|---|
| IPACKInfiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves. | Drug | IPACK |
| PLACEBOThe control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered. | Drug | Placebo |
Primary outcome
Pain Scores
Time frame: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery
Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.
Opioid Consumption
Time frame: 2-3 hours after surgery; 1 week after surgery
Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided. We do not have intentions on sharing IPD with other researchers at this time. If we decide to collaborate in the future, IPD will be de-identified prior to sharing.
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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 Phase 4 study testing IPACK in people with Pain, Postoperative and Anterior Cruciate Ligament Injuries, run by Loyola University 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 4 inclusion and 5 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 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Miller, MD (708-216-8730, johnmiller@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery). The study lists 2 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 14 Aug 2023.