search
Back to results

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

Primary Purpose

ACL, ACL Injury, Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture + Standard of Care
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ACL focused on measuring Acupuncture

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture + Standard of Care

No acupuncture + Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blinding Assessment
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

Numerical Rating System (NRS) Pain at rest scores
Numerical rating score pain at rest on a scale of 0-10
Numerical Rating System (NRS) Pain with movement scores
Numerical rating score pain with movement on a scale of 0-10
Opioid Consumption
cumulative oral morphine equivalent

Full Information

First Posted
October 10, 2018
Last Updated
July 8, 2020
Sponsor
Hospital for Special Surgery, New York
search

1. Study Identification

Unique Protocol Identification Number
NCT03711734
Brief Title
Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Official Title
Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, ACL Injury, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anesthesia
Keywords
Acupuncture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture + Standard of Care
Arm Type
Experimental
Arm Description
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.
Arm Title
No acupuncture + Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture + Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blinding Assessment
Description
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.
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Numerical Rating System (NRS) Pain at rest scores
Description
Numerical rating score pain at rest on a scale of 0-10
Time Frame
postoperative day 1
Title
Numerical Rating System (NRS) Pain with movement scores
Description
Numerical rating score pain with movement on a scale of 0-10
Time Frame
postoperative day 1
Title
Opioid Consumption
Description
cumulative oral morphine equivalent
Time Frame
day of surgery through postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Cheng, MD
Organizational Affiliation
Hospital for Special Surgey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34471447
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs