ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current

SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current

Rotator Cuff Repair

Anterior Cruciate Ligament Reconstruction With a Patella Autograph

Ankle Arthrodesis or Arthroplasty

Hallux Valgus Correction

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)

SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days

SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)

University California San Diego

Naval Medical Center San Diego

Walter Reed National Military Medical Center

Womack Army medical Center

Cleveland Clinic

Brooke Army Medical Center

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Study

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Non-Pharmacologic Alternative for the Treatment of Postoperative Pain

Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point

Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

Cumulative opioid dose of previous 24 hours

Measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

The Brief Pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The Brief Pain Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average", "least", and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0 = complete relief, 10 = no relief]; and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0 = no interference; 10 = complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).

The World Health Organization Quality of Life (WHOQoL-BREF) Instrument is specifically designed to evaluate clinically important, patient-relevant changes in health-related quality of life. The WHOQoL-BREF focuses on those aspects of life most important to patients & is composed of 24 questions assessing 4 dimensions: (1) physical health, (2) psychological health, (3) social relationships, and (4) environment. Two additional items involve individuals' overall perception of their quality of life and health. Each of the 26 questions is rated on a 0-5 scale, and then summed to produce both a total score as well as domain-specific scores for more in depth analysis. Domain scores are scaled in a positive direction. The mean score of items within each domain is used to calculate the domain score. Mean scores are then converted to range between 0-100 to enable comparisons to be made between domains comprised of unequal numbers of questions.

A 20-item self-report measure reflecting symptoms of post-traumatic stress disorder validated in military, Veteran, and civilian populations.

Brian M. Ilfeld, MD, MS

Professor of Anesthesiology, In Residence

University of California, San Diego

Uniformed Services University of the Health Sciences

Wake Forest Medical Center

Augusta University

The Cleveland Clinic

United States Naval Medical Center, San Diego

Palo Alto VA

Womack Army Medical Center

SPR Therapeutics

Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.

Injection of inert placebo solution in surgical field at end of arthroscopic rotator cuff repair.

Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection

Experimental (Liposomal Bupivacaine)

Injection of normal saline in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Normal saline in volume equal to that of the liposomal bupivacine injected in experimental group

Control (Normal Saline)

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Numeric rating score pain level at time of nerve block resolution, on scale of 0-10, as reported by patient at time of 24 hour follow up phone call. A reported score of zero implies no pain, whereas a score of "10" implies very severe pain. Outcome score is mean of reported pain scores by participants at time of nerve block resolution.

Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.

Numeric Rating Pain Score [NRS] at Time of Block Resolution

Mean NRS pain score on scale of 1-10, at rest (zero is no pain, 10 is severe pain). Patients recorded their pain score at rest with administration of each oral analgesic tablet. Outcome score is mean of reported pain scores for this day.

Mean NRS Pain Score at Rest on Postoperative Day 1

Mean of patient-reported NRS pain scores on postoperative day 2. Patients recorded pain scores at rest with each oral analgesic tablet taken. Zero implies no pain, whereas a score of 10 translates to very severe pain. Outcome score is mean of reported pain scores for this day.

Mean NRS Pain Score at Rest on Postoperative Day 2

Patients recorded their pain scores at rest with ingestion of each oral analgesic table on postoperative day 3. Zero implies no pain, whereas 10 implies very severe pain. Outcome score is mean of reported pain scores for this day.

Mean NRS Pain Scores at Rest on Postoperative Day 3

NRS Pain score with passive motion (for those patients who performed this), on 0-10 scale, with zero being no pain and 10 representing severe pain. Outcome score is mean of reported pain scores for passive motion episodes on all three postoperative days.

Mean NRS Pain Score With Motion

Oral analgesic dose (5 mg oxycodone tablets) required expressed as oral morphine equivalents. Outcome is total oral opioid used on postoperative day 1 expressed as oral morphine equivalents in mg.

Oral Analgesic Requirements on Postoperative Day 1

Amount of oral opioids (oxycodone 5 mg tablets) ingested by patients on Postoperative Day 2, expressed as Oral Morphine Equivalents in mg.

Oral Analgesic Requirements on Postoperative Day 2

Patients reported the number of oral analgesic tablets (5 mg oxycodone tablets) ingested on postoperative day 3. This is expressed as Oral Morphine Equivalents in mg.

Oral Analgesic Requirements on Postoperative Day 3

Injection of Placebo solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Normal saline in same volume as exparel injection in experimental group

Overall Study

Dr. Steven L. Orebaugh

Rotator Cuff Tear

Liposomal bupivacaine solution (Exparel) for injection

Liposomal bupivacaine

Inert solution created to appear as liposomal bupivacaine (Exparel) for injection

hallux valgus/vomiting

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Study

Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair

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