N/A
N=40
Acupuncture ACL (Anterior Cruciate Ligament)
ACL · ACL Injury · Anterior Cruciate Ligament Injury · Anterior Cruciate Ligament Rupture · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03711734 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Bang Blinding Index (BI) — 0.2; 0.11 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture + Standard of Care (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bang Blinding Index (BI) |
0.2; 0.11 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain at Rest Scores |
4.3; 4.1 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain With Movement Scores |
5.2; 4.6 | — |
| SECONDARY Opioid Consumption |
47.8; 46.3 | — |
Summary
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing ACL Surgery with a participating surgeon
- English Speaking
- Patients at least 12 years old
- Planned spinal anesthesia without peripheral nerve block (rescue block is okay)
Exclusion Criteria
- Patients under the age of 12
- Non-English speaking patients
- Patients planning on having general anesthesia
- Planned preop peripheral nerve block
- Patients with the inability to understand/follow study protocol
- Patients with pacemaker/AICD
- Non-native Ear/Previous scarring/surgical manipulation of ear
- Patients with contraindications to intra-op protocol
- Chronic pain patients
- Patients who have regularly used opioids for more than 6 weeks prior to surgery
- Patients with guages in their ears
- Patients who refuse to remove earrings/piercings prior to surgery
- Patients with nickel allergies (needles are made of nickel)
Data sourced from ClinicalTrials.gov (NCT03711734). 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.