Acupuncture ACL (Anterior Cruciate Ligament)

NCT03711734 | Completed Results

• 1 other identifier: 2018-1478
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL; ACL Injury; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture; Anesthesia

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (1)

• Bang Blinding Index (BI)

  Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.

  postoperative day 1

Secondary Outcomes (3)

• Numeric Rating Scale (NRS) Pain at Rest Scores

  postoperative day 1

• Numeric Rating Scale (NRS) Pain With Movement Scores

  postoperative day 1

• Opioid Consumption

  day of surgery through postoperative day 1

Study Arms (2)

Acupuncture + Standard of Care

EXPERIMENTAL

Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz.

Other: Acupuncture + Standard of Care

No acupuncture + Standard of Care

NO INTERVENTION

Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally.

Interventions

Acupuncture + Standard of Care OTHER

Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.

Acupuncture + Standard of Care

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.

  PMID: 34471447 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Acupuncture Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Stephanie Cheng
• Organization: Hospital for Special Surgery

chengs@hss.edu

212-606-1206

Study Officials

• Stephanie Cheng, MD

  Hospital for Special Surgey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 18, 2018
• Study Start: November 1, 2018
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: December 27, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)