Phase 4
Completed N=94
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?
Total Knee Athroplasty
Source: ClinicalTrials.gov NCT04749615 ↗
Enrolled (actual)
94
Serious AEs
3.2%
Results posted
Jun 2024
Primary outcomePrimary: Pain Scores (NRS, 0-10) With Ambulation on POD1 — 4.55; 4.26 units on a scale — p=0.11
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is:
• Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?
Participants will be assigned to one of the following groups at random:
* ACB/PACK with PAI
* ACB/IPACK with saline injection
Participants will also be asked to complete pre- and post-operative questionnaires.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores (NRS, 0-10) With Ambulation on POD1 |
4.55; 4.26 | 0.11 |
| SECONDARY Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) |
25.45; 21.98; 25.95; 22.16; 37.3; 28.64 | 0.5 |
| SECONDARY NRS Pain With Movement |
5.17; 5.85; 5.7; 5.19; 4.55; 4.26 | — |
| SECONDARY Numerical Rating Scale (NRS) Pain Score at Rest |
1.19; 1.79; 5.66; 5.06; 2.36; 2.47 | — |
| SECONDARY PAIN OUT Questionnaire at Preoperation |
0.96; 1.45; 6.57; 6.79; 3.11; 3.02 | — |
| SECONDARY Quality of Recovery (POD1) |
16.62; 16.96 | — |
| SECONDARY Side Effects: Opioid-Related Symptom Distress Score (POD1) |
.55; .74 | — |
| SECONDARY Satisfaction With Pain Management (POD1) |
9.7; 9.66 | — |
| SECONDARY Blinding Assessment; Bang Question (POD1) |
10; 8; 13; 17; 24; 22 | — |
| SECONDARY Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months |
2.79; 2.62; 2.63; 2.78 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement |
50.7; 49.61; 78.31; 77.05; 83.39; 83.60 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 1 |
1.17; 1.34; 6.53; 6.15; 2.32; 2.4 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 14 |
1.72; 1.54; 5.6; 5.26; 2.68; 2.09 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 90 |
.05; .24; 1.68; 1.81; .29; .89 | — |
| SECONDARY PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief |
17.02; 18.09; 5.5; 6.14 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief |
12.55; 11.49; 9.93; 10.14 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief |
14.47; 17.61; 9.65; 9.5 | — |
| SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief |
9.02; 7.57; 10.12; 10.37 | — |
Eligibility Criteria
Inclusion Criteria
- Planned use of regional anesthesia
- Ability to follow the major components of the study protocol
- English speaking (Secondary outcomes include questionnaires validated in English only)
Exclusion Criteria
- Patients younger than 25 years old and older than 80
- Non-English speaking
- Patients intending to receive general anesthesia
- Contraindication to nerve blocks or peri-articular injection
- Patients with an ASA of IV or higher
- Renal insufficiency (ESRD, HD, estimated creatinine clearance < 30 ml/min)
- Patients with major prior ipsilateral open knee surgery
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months)
Data sourced from ClinicalTrials.gov (NCT04749615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.