A Phase 4 interventional study of Bupivacaine and Ultrasound in Anterior Cruciate Ligament Injury, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 13 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
Among 11 studies testing bupivacaine in Anterior Cruciate Ligament Injuries — 1 open to participants now, 1 under way, none of them phase 3. Bupivacaine · Anterior Cruciate Ligament Injuries.
Among the 11 studies testing bupivacaine in Anterior Cruciate Ligament Injuries, this one is the 4th largest by enrollment, is the only one that started in 2017, is one of 4 in phase 4, and was the 5th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's enrollment of 78 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →1 of the 11 studies testing bupivacaine in Anterior Cruciate Ligament Injuries is open now, in 1 country. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 121 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 91 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 13 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2017.
Median enrollment 59 across the 11 interventional studies. Of the 8 that completed or were terminated, 6 (75%) have results posted.
None of the 11 has an industry lead sponsor. The 10 most frequent:
Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Hospital for Special Surgery, New York has 7 studies filed under Anterior Cruciate Ligament Injuries — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing bupivacaine in Anterior Cruciate Ligament Injuries, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivacaine · Device: Ultrasound · Drug: Dexamethasone
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.
Drug: Bupivacaine · Device: Ultrasound · Drug: Dexamethasone
Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone will be used to prolong block duration
Also known as: preservative free Dexamethasone
Pain While at Rest
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Time frame: 24 hours post-block administration
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.
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
NRS Pain score with ambulation \& stairs. A lower score is a better outcome. Score range is from 0 to 10.
Time frame: 3 hours post-block administration on Post-operative day (POD) 0
| Milestone | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) |
|---|---|---|
| Started | 39 | 39 |
| Completed | 39 | 39 |
| Not completed | 0 | 0 |
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
| score on a scale | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) |
|---|---|---|
| Pain While at Rest | 3.84 ± 1.86 | 3.95 ± 2.58 |
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.
| minutes | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) |
|---|---|---|
| Discharge Criteria | 180.67 ± 143.84 | 189.92 ± 254.55 |
NRS Pain score with ambulation \& stairs. A lower score is a better outcome. Score range is from 0 to 10.
| score on a scale | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) |
|---|---|---|
| NRS with Ambulation | 1.59 ± 1.43 | 1.26 ± 1.23 |
| NRS with Stairs | 2.05 ± 1.92 | 2.1 ± 1.81 |
Collected over up to 7 days after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adductor Canal Block (ACB) | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Adductor Canal Block & IPACK (ACB/IPACK) | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Continuous(years) | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) | Total |
|---|---|---|---|
| Mean | 23 ± 7 | 25 ± 8 | 24 ± 7 |
| Sex: Female, Male(Participants) | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) | Total |
|---|---|---|---|
| Female | 13 | 12 | 25 |
| Male | 26 | 27 | 53 |
| Race (NIH/OMB)(Participants) | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 6 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 26 | 20 | 46 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 8 | 12 |
| Region of Enrollment(participants) | Adductor Canal Block (ACB) | Adductor Canal Block & IPACK (ACB/IPACK) | Total |
|---|---|---|---|
| United States | 39 | 39 | 78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Bupivacaine · Dexamethasone
Anterior Cruciate Ligament Injuries →
Hospital for Special Surgery, New York →