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Phase 4 Completed N=111 Randomized Double-blind Treatment

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Source: ClinicalTrials.gov NCT02292082 ↗
Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Time to Meet Physical Therapy Discharge Criteria — 2109.3; 1883.1 Minutes
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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

Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Meet Physical Therapy Discharge Criteria
2109.3; 1883.1
SECONDARY
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
4.3; 3.9
SECONDARY
NRS Pain Score With Movement POD2
4.7; 5.2
SECONDARY
Opioid Consumption Postoperative Day (POD) 1
58.4; 47.5
SECONDARY
Opioid Consumption POD2
67.9; 60.1
SECONDARY
Hospital Length of Stay
3491; 3394.4
SECONDARY
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
1.5; 0.8
SECONDARY
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
1.7; 1.8
SECONDARY
Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
6.7; 5.3
SECONDARY
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
6.9; 6.6
SECONDARY
Knee Society Score (KSS) at 6 Weeks Postoperatively
85.2; 75.2

Eligibility Criteria

Inclusion Criteria

  • Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
  • Age 18 to 80 years
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion Criteria

Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02292082). 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.

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