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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

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
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.
Change History Complete list of historical versions of study NCT03711734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • 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
  • 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
  • Opioid Consumption [ Time Frame: day of surgery through postoperative day 1 ]
    cumulative oral morphine equivalent
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Official Title  ICMJE Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • ACL
  • ACL Injury
  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture
  • Anesthesia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Acupuncture + Standard of Care
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03711734
Other Study ID Numbers  ICMJE 2018-1478
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Cheng, MD Hospital for Special Surgey
PRS Account Hospital for Special Surgery, New York
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP