N/A
Completed N=41
Acupuncture for Low-Dose Opioid for TKA Replacement
Knee Osteoarthritis · Pain, Postoperative · Acupuncture
Source: ClinicalTrials.gov NCT04084288 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Low-dose Opioid Regimen Adherence — 26 participants
Summary
The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low-dose Opioid Regimen Adherence |
26 | — |
| SECONDARY Total Opioid Consumption |
14.9; 11.9; 7.3; 13.5; 108.3; 0 | — |
| SECONDARY Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement |
5.1; 4.2; 3.7; 3.7; 3; 2.4 | — |
| SECONDARY Duration of Neuraxial Anesthesia in Hours |
2.6 | — |
| SECONDARY Deviation From Prescribed Oral Pain Regimen |
1; 0 | — |
| SECONDARY Number of Participants With Side Effects on POD1 and During the PACU Stay |
11; 7; 4; 0; 3; 0 | — |
| SECONDARY Postoperative Range of Motion |
113.2 | — |
| SECONDARY Tourniquet Time |
60.5 | — |
Eligibility Criteria
Inclusion Criteria
- ASA of 1 or 2
- Age 18-70
- Undergoing primary total knee replacement
- Desire to attempt a low opioid or opioid free pathway
Exclusion Criteria
- NonEnglish speaking
- Patients with the inability to understand or follow study protocol
- Opioid use in the last 6 weeks or chronic pain patient
- Cannot receive neuraxial anesthesia and/or peripheral nerve block
- Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
- Patients with implanted cardiac device such as a pacemaker or AICD
- Active ear infection
- Nonnative ear, previous scarring or surgical manipulation of ear
- Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
- Allergy to nickel
Data sourced from ClinicalTrials.gov (NCT04084288). 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.