Trial Outcomes & Findings for Auriculotherapy for Surgical Pain (NCT NCT03860259)

NCT ID: NCT03860259

Last Updated: 2022-03-17

Results Overview

Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
• Results posted on: 2022-03-17

Participant Flow

Patients were recruited in the pre-operative holding area of UPMC Shadyside or UPMC Montefiore Hospitals on the day of their scheduled rotator cuff surgery. Recruitment began on January 24, 2020 and concluded on July 1, 2021. During this time, recruitment was on hold due to COVID-19 protocol from February to July of 2020.

A total of 50 subjects signed an informed consent and all subjects were randomized to either the placebo or intervention group. No subjects were excluded prior to randomization.

Participant milestones

Measure	Auriculotherapy Without Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Overall Study STARTED	25	25
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Auriculotherapy Without Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Overall Study Lost to Follow-up	5	5
Overall Study Protocol Violation	1	0

Baseline Characteristics

Auriculotherapy for Surgical Pain

Baseline characteristics by cohort

Measure	Auriculotherapy Without Nitrogen Gas n=25 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=25 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	61.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	61.4 years STANDARD_DEVIATION 9.9 • n=7 Participants	61.2 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Height	170.2 centimeters STANDARD_DEVIATION 12.4 • n=5 Participants	169.1 centimeters STANDARD_DEVIATION 10.2 • n=7 Participants	169.6 centimeters STANDARD_DEVIATION 11.0 • n=5 Participants
Weight	85.9 kilograms STANDARD_DEVIATION 17.8 • n=5 Participants	94.7 kilograms STANDARD_DEVIATION 27.2 • n=7 Participants	90.3 kilograms STANDARD_DEVIATION 23.0 • n=5 Participants
Body Mass Index	29.6 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants	32.8 kg/m^2 STANDARD_DEVIATION 7.5 • n=7 Participants	31.2 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Opioid Consumption Following Rotator Cuff Surgery 24 Hours	31 oral morphine mg equivalents (OME) Standard Deviation 20	25 oral morphine mg equivalents (OME) Standard Deviation 20
Opioid Consumption Following Rotator Cuff Surgery 48 Hours	25 oral morphine mg equivalents (OME) Standard Deviation 17	21 oral morphine mg equivalents (OME) Standard Deviation 17
Opioid Consumption Following Rotator Cuff Surgery 72 Hours	19 oral morphine mg equivalents (OME) Standard Deviation 19	12 oral morphine mg equivalents (OME) Standard Deviation 13
Opioid Consumption Following Rotator Cuff Surgery 96 Hours	12 oral morphine mg equivalents (OME) Standard Deviation 15	9 oral morphine mg equivalents (OME) Standard Deviation 10
Opioid Consumption Following Rotator Cuff Surgery 120 Hours	10 oral morphine mg equivalents (OME) Standard Deviation 13	5 oral morphine mg equivalents (OME) Standard Deviation 7
Opioid Consumption Following Rotator Cuff Surgery Total	96 oral morphine mg equivalents (OME) Standard Deviation 67	62 oral morphine mg equivalents (OME) Standard Deviation 46

SECONDARY outcome

Timeframe: 24 hrs through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Numerical Rating Scale (NRS) Pain with movement on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Post-Operative Pain With Movement 24 Hours	8.11 score on a scale Standard Deviation 2.11	7.42 score on a scale Standard Deviation 2.67
Post-Operative Pain With Movement 48 Hours	6.83 score on a scale Standard Deviation 2.28	6.21 score on a scale Standard Deviation 2.70
Post-Operative Pain With Movement 72 Hours	6.28 score on a scale Standard Deviation 2.19	5.37 score on a scale Standard Deviation 2.22
Post-Operative Pain With Movement 96 Hours	5.44 score on a scale Standard Deviation 2.59	4.65 score on a scale Standard Deviation 2.30
Post-Operative Pain With Movement 120 Hours	4.72 score on a scale Standard Deviation 2.61	3.80 score on a scale Standard Deviation 2.28
Post-Operative Pain With Movement Day 14	5.84 score on a scale Standard Deviation 2.39	4.47 score on a scale Standard Deviation 2.12
Post-Operative Pain With Movement Day 30	5.00 score on a scale Standard Deviation 2.78	5.27 score on a scale Standard Deviation 2.84
Post-Operative Pain With Movement Day 60	4.15 score on a scale Standard Deviation 3.48	3.64 score on a scale Standard Deviation 2.90
Post-Operative Pain With Movement Day 90	2.21 score on a scale Standard Deviation 1.85	2.00 score on a scale Standard Deviation 2.61

SECONDARY outcome

Timeframe: Time of discharge through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Numerical Rating Scale (NRS) pain at rest on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Post-Operative Pain at Rest Discharge	0.89 score on a scale Standard Deviation 1.91	0.45 score on a scale Standard Deviation 0.76
Post-Operative Pain at Rest 24 Hours	6.17 score on a scale Standard Deviation 3.01	5.75 score on a scale Standard Deviation 3.32
Post-Operative Pain at Rest 48 Hours	4.67 score on a scale Standard Deviation 3.18	4.50 score on a scale Standard Deviation 2.69
Post-Operative Pain at Rest 72 Hours	3.89 score on a scale Standard Deviation 2.72	3.50 score on a scale Standard Deviation 2.19
Post-Operative Pain at Rest 96 Hours	3.50 score on a scale Standard Deviation 2.41	3.45 score on a scale Standard Deviation 2.44
Post-Operative Pain at Rest 120 Hours	2.88 score on a scale Standard Deviation 2.00	2.65 score on a scale Standard Deviation 2.28
Post-Operative Pain at Rest Day 14	2.26 score on a scale Standard Deviation 1.59	1.71 score on a scale Standard Deviation 1.76
Post-Operative Pain at Rest Day 30	2.13 score on a scale Standard Deviation 2.00	1.20 score on a scale Standard Deviation 1.37
Post-Operative Pain at Rest Day 60	1.23 score on a scale Standard Deviation 2.05	1.21 score on a scale Standard Deviation 1.67
Post-Operative Pain at Rest Day 90	0.43 score on a scale Standard Deviation 0.76	0.38 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Day of surgery through 5-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Non-narcotic Analgesic Consumption Ibuprofen	785.26 milligrams Standard Deviation 1576.68	1370.00 milligrams Standard Deviation 2386.17
Non-narcotic Analgesic Consumption Acetaminophen	4438.16 milligrams Standard Deviation 4066.01	5955.63 milligrams Standard Deviation 5882.27

SECONDARY outcome

Timeframe: Day of surgery through 90 days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 67.37178 and the lowest possible score is 17.57825. Higher scores for both represent better functioning.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Baseline PCS	38.9 score on a scale Standard Deviation 8.4	38.0 score on a scale Standard Deviation 6.6
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 14 PCS	37.1 score on a scale Standard Deviation 8.2	34.0 score on a scale Standard Deviation 4.6
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 30 PCS	36.1 score on a scale Standard Deviation 7.6	35.7 score on a scale Standard Deviation 4.7
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 60 PCS	40.5 score on a scale Standard Deviation 9.2	39.0 score on a scale Standard Deviation 8.4
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 90 PCS	44.1 score on a scale Standard Deviation 8.4	44.9 score on a scale Standard Deviation 7.8
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Baseline MCS	60.5 score on a scale Standard Deviation 4.4	59.4 score on a scale Standard Deviation 3.8
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 14 MCS	57.4 score on a scale Standard Deviation 8.1	60.3 score on a scale Standard Deviation 5.3
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 30 MCS	61.3 score on a scale Standard Deviation 5.1	59.6 score on a scale Standard Deviation 4.6
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 60 MCS	59.9 score on a scale Standard Deviation 5.5	58.6 score on a scale Standard Deviation 3.9
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) Day 90 MCS	60.8 score on a scale Standard Deviation 2.5	58.3 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Day of surgery through recovery room discharge, up to 142 min post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Length of Recovery Room Stay	59.5 minutes Standard Deviation 25.7	67.2 minutes Standard Deviation 34.1

SECONDARY outcome

Timeframe: Day of surgery through time of discharge, up to 270 min post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Evaluate time to hospital discharge from out of OR time in minutes

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Length of Hospital Stay	140.1 minutes Standard Deviation 32.1	148.0 minutes Standard Deviation 47.4

SECONDARY outcome

Timeframe: Day of surgery through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

The number of participants who experienced complications and received the standard protocol versus subjects who received the standard protocol + Auriculotherapy. Post-operative complications can be defined as unexpected problems that arise following surgery including increased bleeding, infection, recurrent rotator cuff tear, and displacement of suture anchor.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Number of Participants Who Experienced Post-operative Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day of surgery through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Evaluate the number of subjects readmitted because of pain or pain-related issues during the 90 day study duration

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Subjects Requiring Readmission Due to Pain	0 participants	0 participants

SECONDARY outcome

Timeframe: Day of surgery through time of discharge, up to 270 min post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Overall Patient Satisfaction	9.2 score on a scale Standard Deviation 2.1	9.6 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Day of surgery through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Participants are asked to assess their satisfaction with pain management at discharge, 24 hrs, 48 hrs, 72 hrs, 96, hours, 120 hrs and 14 days, 30 days, 60 days and 90 days post-operative on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Satisfaction With Pain Management Discharge	5.7 score on a scale Standard Deviation 0.7	5.9 score on a scale Standard Deviation 0.4
Satisfaction With Pain Management 24 Hours	4.2 score on a scale Standard Deviation 1.8	4.1 score on a scale Standard Deviation 1.4
Satisfaction With Pain Management 48 Hours	4.7 score on a scale Standard Deviation 1.2	4.6 score on a scale Standard Deviation 1.1
Satisfaction With Pain Management 72 Hours	5.1 score on a scale Standard Deviation 0.8	4.9 score on a scale Standard Deviation 1.0
Satisfaction With Pain Management 96 Hours	4.7 score on a scale Standard Deviation 1.5	4.6 score on a scale Standard Deviation 1.3
Satisfaction With Pain Management 120 Hours	4.8 score on a scale Standard Deviation 1.5	4.8 score on a scale Standard Deviation 1.1
Satisfaction With Pain Management Day 14	5.6 score on a scale Standard Deviation 0.8	5.6 score on a scale Standard Deviation 0.8
Satisfaction With Pain Management Day 30	5.4 score on a scale Standard Deviation 1.2	5.7 score on a scale Standard Deviation 0.5
Satisfaction With Pain Management Day 60	5.2 score on a scale Standard Deviation 1.6	5.3 score on a scale Standard Deviation 1.5
Satisfaction With Pain Management Day 90	4.9 score on a scale Standard Deviation 1.9	5.9 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Day of surgery through 90-days post-operative

Population: Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia

Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.

Outcome measures

Measure	Auriculotherapy Without Nitrogen Gas n=19 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 Participants Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Subjects Requiring Hospital Readmission	0 Participants	0 Participants

Adverse Events

Auriculotherapy Without Nitrogen Gas

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Auriculotherapy With Nitrogen Gas

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Auriculotherapy Without Nitrogen Gas n=19 participants at risk；n=25 participants at risk Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy	Auriculotherapy With Nitrogen Gas n=20 participants at risk；n=25 participants at risk Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Gastrointestinal disorders Postoperative Constipation	21.1% 4/19 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative). Adverse event data was collected for the duration of the subject's 90-day study participation using the electronic medical record and via patient report at day 5, 14, 30, 60, and 90 follow-ups.	50.0% 10/20 • Number of events 10 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative). Adverse event data was collected for the duration of the subject's 90-day study participation using the electronic medical record and via patient report at day 5, 14, 30, 60, and 90 follow-ups.

Additional Information

Jacques E. Chelly, MD, PhD, MBA

University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine

Phone: 412-623-6382

Email: chelje@anes.upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place