NCT05498870

iPACK for Post-op Pain Following ACL Reconstruction

Completed Phase 4 Results posted Last updated 16 October 2024

What this trial tests

Phase 4 trial testing Adductor Canal Block (ACB) Only in ACL Injury in 82 participants. Completed in 14 August 2023.

Timeline

25 August 2022

Primary endpoint
3 July 2023

14 August 2023

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	82
Start date	25 August 2022
Primary completion	3 July 2023
Estimated completion	14 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Adductor Canal Block (ACB) Only — full drug profile →
• Adductor Canal Block (ACB) + iPACK Block — full drug profile →

Conditions studied

• ACL Injury — all drugs for ACL Injury →
• Post Operative Pain — all drugs for Post Operative Pain →

Sponsor

Medical University of South Carolina

Who can join

12 and older, any sex, with ACL Injury or Post Operative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Scores Primary · 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.

Pain at Discharge

Group	Value	95% CI
Adductor Canal Block (ACB) Only	41.5	± 27.3
ACB + iPACK	29.8	± 20.5

12 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	37.9	± 4.22
ACB + iPACK	47.4	± 4.02

24 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	38.7	± 4.05
ACB + iPACK	49.9	± 4.32

36 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	40.9	± 4.84
ACB + iPACK	54.7	± 4.35

48 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	40.2	± 4.66
ACB + iPACK	50.8	± 4.68

60 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	41.1	± 4.39
ACB + iPACK	44.2	± 4.2

72 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	36.2	± 4.8
ACB + iPACK	36.7	± 4.15

Total Postoperative Opioid Consumption (Total MME) Secondary · up to 72 hours post-op

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.

12 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	8.26	± 1.99
ACB + iPACK	11.2	± 1.93

24 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	6.09	± 1.98
ACB + iPACK	10.5	± 2.05

36 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	10.4	± 2.48
ACB + iPACK	16.2	± 2.97

48 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	6.51	± 2.15
ACB + iPACK	10.5	± 2.43

60 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	10.5	± 2.52
ACB + iPACK	14.5	± 2.55

72 hours post-op

Group	Value	95% CI
Adductor Canal Block (ACB) Only	6.65	± 2.18
ACB + iPACK	7.65	± 2.66

Range of Motion (Degrees) Secondary · up to two months after surgery

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.

Group	Value	95% CI
Adductor Canal Block (ACB) Only	90.0	± 2.38
ACB + iPACK	99.3	± 2.23

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adductor Canal Block (ACB) Only

Serious: 0/34 (0%)

Deaths: 0/34

ACB + iPACK

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (2 terms — click to expand)

Reaction	System	Adductor Canal Block (ACB)…	ACB + iPACK
Surgical Adverse Event	Surgical and medical procedures	—	—
Nerve Block Adverse Event	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT05498870 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.