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N/A N=50 Randomized Triple-blind Treatment

Auriculotherapy for Surgical Pain

Acute Pain · Surgery · Shoulder Pain

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Opioid Consumption Following Rotator Cuff Surgery — 31; 25; 25; 21 oral morphine mg equivalents (OME) — p=0.1771

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Auriculotherapy cryopuncture device without nitrogen gas (Device); Auriculotherapy cryopuncture device with nitrogen gas (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jacques E. Chelly
Primary completion
Jul 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Opioid Consumption Following Rotator Cuff Surgery
31; 25; 25; 21; 19; 12 0.1771
SECONDARY
Post-Operative Pain With Movement
8.11; 7.42; 6.83; 6.21; 6.28; 5.37 0.1956
SECONDARY
Post-Operative Pain at Rest
0.89; 0.45; 6.17; 5.75; 4.67; 4.50 0.1707
SECONDARY
Non-narcotic Analgesic Consumption
4438.16; 5955.63; 785.26; 1370.00 0.1786
SECONDARY
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)
38.9; 38.0; 37.1; 34.0; 36.1; 35.7 0.3638
SECONDARY
Length of Recovery Room Stay
59.5; 67.2 0.2220
SECONDARY
Length of Hospital Stay
140.1; 148.0 0.2856
SECONDARY
Number of Participants Who Experienced Post-operative Complications
0; 0
SECONDARY
Subjects Requiring Readmission Due to Pain
0; 0
SECONDARY
Overall Patient Satisfaction
9.2; 9.6 0.2241
SECONDARY
Satisfaction With Pain Management
5.7; 5.9; 4.2; 4.1; 4.7; 4.6 0.2714
SECONDARY
Subjects Requiring Hospital Readmission
0; 0

Summary

The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and electro-stimulation. This study is purposely based on the use of a cryopuntor device, which has been shown to produce the same effect as needles. This is a novel complementary approach to reducing the persistence of opioid prescription following rotator cuff surgery, which is considered a model of severe functional pain. Data obtained from this study will support a future NIDA proposal to expand the use of auriculotherapy for perioperative management of pain and functional recovery associated with surgery. The use of an auriculotherapy approach has the potential of providing effective non-opioid analgesia to patients not only undergoing rotator cuff surgery, but also other surgical models.

Eligibility Criteria

Inclusion Criteria

  • Subject is greater than 18 years of age
  • Subject is willing and able to provide informed consent
  • Subject is scheduled to undergo elective rotator cuff surgery
  • Subject has consented to an interscalene block

Exclusion Criteria

  • Opioid dependence
  • Any subject diagnosed with a chronic pain condition which daily opioid use is needed
  • Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
  • Raynaud's disease diagnosis
  • Vasculopathy
  • Patient refusal
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03860259). 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.

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