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Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03711734
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
ACL ACL Injury Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Anesthesia Other: Acupuncture + Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture + Standard of Care

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
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.

No Intervention: No acupuncture + Standard of Care

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.




Primary Outcome Measures :
  1. Blinding Assessment [ Time Frame: postoperative day 1 ]
    Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 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.


Secondary Outcome Measures :
  1. Numerical Rating System (NRS) Pain at rest scores [ Time Frame: postoperative day 1 ]
    Numerical rating score pain at rest on a scale of 0-10

  2. Numerical Rating System (NRS) Pain with movement scores [ Time Frame: postoperative day 1 ]
    Numerical rating score pain with movement on a scale of 0-10

  3. Opioid Consumption [ Time Frame: day of surgery through postoperative day 1 ]
    cumulative oral morphine equivalent



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711734


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Stephanie Cheng, MD Hospital for Special Surgey

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03711734     History of Changes
Other Study ID Numbers: 2018-1478
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
Acupuncture

Additional relevant MeSH terms:
Wounds and Injuries
Pain, Postoperative
Rupture
Anterior Cruciate Ligament Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Knee Injuries
Leg Injuries