Anterior Cruciate Ligament InjuryPhase 4NCT03292926
A Novel Analgesia Technique for ACL Reconstruction
A Phase 4 study testing Bupivacaine, Ultrasound and Dexamethasone in people with Anterior Cruciate Ligament Injury, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 13 to 80 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Bupivacaine, Ultrasound and Dexamethasone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 16 Apr 2020
- 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 13 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing BTB ACL reconstruction with participating surgeon
- Age 13 or greater
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
Who cannot join
- Hepatic or renal insufficiency
- Younger than 13 years old
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
- Diabetes
Show all 10Show fewer
- American Society of Anesthesiology (ASA) score IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10023
About this study
Official title: A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Bupivacaine, Ultrasound, Dexamethasone
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivacaine will help treat pain and sensation after ACL repair
UltrasoundDevice
Ultrasound will guide anesthesiologist in performing the different nerve blocks
DexamethasoneDrug
Also called preservative free Dexamethasone
Dexamethasone will be used to prolong block duration
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block (ACB) | Active comparator | The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. Receives: Drug: Bupivacaine; Device: Ultrasound; Drug: Dexamethasone |
| Adductor Canal Block & IPACK (ACB/IPACK) | Active comparator | The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone. Receives: Drug: Bupivacaine; Device: Ultrasound; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain While at Rest
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Measured: 24 hours post-block administration
Secondary outcomes (2)
Discharge Criteria
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
Measured: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
Pain With Ambulation
NRS Pain score with ambulation \& stairs. A lower score is a better outcome. Score range is from 0 to 10.
Measured: 3 hours post-block administration on Post-operative day (POD) 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start4 Oct 2017
- Primary completion6 Mar 2020
- Study completion16 Apr 2020
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.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Beathe, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292926
- Sponsor's protocol ID
- 2017-0934
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
- ClinicalTrials.gov ID
- NCT03292926
- Acronym / sponsor ID
- 2017-0934
- Conditions
- Anterior Cruciate Ligament Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Posted 12 May 2022
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 anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block (ACB) | Active comparator | Drug: Bupivacaine, Device: Ultrasound, Drug: DexamethasoneThe adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. |
| Adductor Canal Block & IPACK (ACB/IPACK) | Active comparator | Drug: Bupivacaine, Device: Ultrasound, Drug: DexamethasoneThe adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone. |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing BTB ACL reconstruction with participating surgeon
- Age 13 or greater
- 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 13 years old
- 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 |
|---|---|---|
| BupivacaineBupivacaine will help treat pain and sensation after ACL repair | Drug | Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB) |
| UltrasoundUltrasound will guide anesthesiologist in performing the different nerve blocks | Device | Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB) |
| DexamethasoneAlso: preservative free DexamethasoneDexamethasone will be used to prolong block duration | Drug | Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB) |
Primary outcome
Pain While at Rest
Time frame: 24 hours post-block administration
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
2 secondary outcomes
Discharge Criteria
Time frame: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
Pain With Ambulation
Time frame: 3 hours post-block administration on Post-operative day (POD) 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jonathan Beathe, 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, Ultrasound and Dexamethasone in people with Anterior Cruciate Ligament Injury, 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 5 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 19 Sep 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 12 May 2022). 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 While at Rest (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?
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 Sep 2024.