Clinical trial
Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair
Name
123191
Description
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
Trial arms
Trial start
2019-01-22
Estimated PCD
2020-12-31
Trial end
2020-12-31
Status
Completed
Phase
Early phase I
Treatment
Celecoxib
Post-Operative Non Opioid Pain Protocol
Arms:
Post-Operative Non Opioid Pain Protocol
Other names:
Celebrex
Ketorolac
Post-Operative Non Opioid Pain Protocol
Arms:
Post-Operative Non Opioid Pain Protocol
Other names:
Tylenol
Gabapentin
Post-Operative Non Opioid Pain Protocol
Arms:
Post-Operative Non Opioid Pain Protocol
Other names:
Neurontin
Acetaminophen
Post-Operative Non Opioid Pain Protocol
Arms:
Post-Operative Non Opioid Pain Protocol
Other names:
Tylenol
Diazepam
Post-Operative Non Opioid Pain Protocol
Arms:
Post-Operative Non Opioid Pain Protocol
Other names:
Valium
Hydrocodone-Acetaminophen
Traditionally used narcotic pain protocol
Arms:
Post-Operative Traditional Pain Protocol
Other names:
Norco
Size
70
Primary endpoint
Pain Levels
day 10 post-operative
Patient-Reported Outcomes Measurement Information System
day 10 post-operative
Eligibility criteria
Inclusion Criteria:
* All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair
Exclusion Criteria:
* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2024-04-02
1 organization
4 products
1 drug
1 indication
Organization
Henry Ford Health SystemDrug
CelecoxibIndication
Rotator Cuff TearProduct
KetorolacProduct
GabapentinProduct
AcetaminophenProduct
Diazepam