Rotator Cuff Tear
Conditions
Brief summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty. Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia Primary endpoints is reduction in pain as measured by visual analogue scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure. Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Interventions
DRUGCelecoxib
Post-Operative Non Opioid Pain Protocol
DRUGKetorolac
Post-Operative Non Opioid Pain Protocol
DRUGGabapentin
Post-Operative Non Opioid Pain Protocol
DRUGAcetaminophen
Post-Operative Non Opioid Pain Protocol
DRUGDiazepam
Post-Operative Non Opioid Pain Protocol
Traditionally used narcotic pain protocol
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels | day 10 post-operative | Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control. |
| Patient-Reported Outcomes Measurement Information System | day 10 post-operative | Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post-Operative Non Opioid Pain Protocol Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol | 17 |
| Post-Operative Traditional Pain Protocol Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol | 23 |
| Total | 40 |
Baseline characteristics
| Characteristic | Post-Operative Non Opioid Pain Protocol | Post-Operative Traditional Pain Protocol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 20 Participants | 36 Participants |
| Age, Continuous | 53.7 years STANDARD_DEVIATION 9.1 | 55.9 years STANDARD_DEVIATION 7.2 | 54.2 years STANDARD_DEVIATION 8.7 |
| Anchors used in Surgery | 2.7 number of anchors used STANDARD_DEVIATION 0.8 | 2.6 number of anchors used STANDARD_DEVIATION 1.1 | 2.6 number of anchors used STANDARD_DEVIATION 0.9 |
| BMI | 32.2 kg/m2 STANDARD_DEVIATION 6.8 | 29.9 kg/m2 STANDARD_DEVIATION 5.5 | 30.8 kg/m2 STANDARD_DEVIATION 5.7 |
| Concomitant procedures Biceps Tenodesis | 4 Participants | 3 Participants | 7 Participants |
| Concomitant procedures Biceps Tenotomy | 2 Participants | 2 Participants | 4 Participants |
| Concomitant procedures DCE | 1 Participants | 2 Participants | 3 Participants |
| Concomitant procedures None | 0 Participants | 2 Participants | 2 Participants |
| Concomitant procedures SAD | 10 Participants | 14 Participants | 24 Participants |
| Preoperative block Interscalene | 14 Participants | 18 Participants | 32 Participants |
| Preoperative block Supraclavicular | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 21 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
| Tear size 1-3cm | 11 Participants | 16 Participants | 27 Participants |
| Tear size 3-5cm | 5 Participants | 2 Participants | 7 Participants |
| Tear size greater than 5cm | 0 Participants | 1 Participants | 1 Participants |
| Tear size less than 1 cm | 1 Participants | 4 Participants | 5 Participants |
| Tendons involved in surgery | 1.7 number of tendons involved STANDARD_DEVIATION 0.4 | 1.4 number of tendons involved STANDARD_DEVIATION 0.8 | 1.55 number of tendons involved STANDARD_DEVIATION 0.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 23 |
| other Total, other adverse events | 8 / 17 | 10 / 23 |
| serious Total, serious adverse events | 0 / 17 | 0 / 23 |
Outcome results
Primary
Pain Levels
Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.
Time frame: day 10 post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Pain Levels | 2.4 units on a scale | Standard Deviation 2.1 |
| Post-Operative Traditional Pain Protocol | Pain Levels | 3 units on a scale | Standard Deviation 1.8 |
Primary
Patient-Reported Outcomes Measurement Information System
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.
Time frame: day 10 post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Patient-Reported Outcomes Measurement Information System | 59.3 units on a scale | Standard Deviation 8.5 |
| Post-Operative Traditional Pain Protocol | Patient-Reported Outcomes Measurement Information System | 60.0 units on a scale | Standard Deviation 9.3 |