Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/31/2018 |
Start Date: | October 2015 |
End Date: | October 2020 |
Contact: | C. Benjamin Ma, MD |
Email: | Maben@ucsf.edu |
This will be a randomized controlled trial to determine if postoperative ibuprofen after
arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog
Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog
Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Patients will be randomized into two cohorts:
1. Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard
opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic
for postoperative pain control.
2. Placebo tablet by mouth three times daily. Patients will also received the standard
opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic
for postoperative pain control.
Patients will be screened for the study at the preoperative clinic vist and randomized on the
day of surgery if they meet our inclusion criteria.
Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2
years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be
assessed at every visit. Functional shoulder outcomes including shoulder range of motion and
the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as
well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be
completed at the preoperative visit and final follow-up visit only. We will assess rotator
cuff repair integrity with ultrasound study at 1 year after surgery
1. Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard
opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic
for postoperative pain control.
2. Placebo tablet by mouth three times daily. Patients will also received the standard
opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic
for postoperative pain control.
Patients will be screened for the study at the preoperative clinic vist and randomized on the
day of surgery if they meet our inclusion criteria.
Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2
years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be
assessed at every visit. Functional shoulder outcomes including shoulder range of motion and
the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as
well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be
completed at the preoperative visit and final follow-up visit only. We will assess rotator
cuff repair integrity with ultrasound study at 1 year after surgery
Inclusion Criteria:
- Patients 18 years or older
- Patients that undergo arthroscopic rotator cuff repair only
Exclusion Criteria:
- Patients less than 18 years of age, pregnant, are incarcerated. Women who are not
post-menopause are screened for pregnancy preoperatively with a urine test per our
UCSF Orthopaedic Institute preoperative guidelines.
- Patients who are unable to and not willing to comply with the study protocol and
follow-up visits
- Patients with a history of prior rotator cuff repair
- Patients with rotator cuff tears that require open repair
- Patients with an allergy to ibuprofen or anti-inflammatory medications
- Patients with a medical chart record or those who report a history of upper
gastroenterology bleed or gastic ulcers
- Patients who are currently on warfarin, enoxaparin, heparin, or a factor Xa inhibiting
anti-coagulation medication
- Patients with a known past medical history of chronic kidney disease, history of
kidney transplant, or eGFR < 60 mL/min per 1.73m2.
We found this trial at
1
site
San Francisco, California 94158
Principal Investigator: Chunbong B Ma, MD
Phone: 415-514-6120
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