Skip to main content
OpenTrials
Completed

NCT Number: NCT02588027

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Tear Arthropathy Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Orthopaedic Institute

San Francisco, California, 94143, United States

About this study

Patients will be randomized into two cohorts:

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 gastric 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.

Treatment and study plan

Ibuprofen

Drug

Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.

Other names: Advil, Motrin

Placebo

Drug

Pharmacy formulated placebo

Primary outcomes

  1. Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo

    Time frame: 1 week post operative

    pain control

Secondary outcomes

  1. Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)

    Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

    American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities).

  2. Assessment of Functional Shoulder Outcome Score: DASH

    Time frame: preop, 1 year postop

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome

  3. Assessment of Functional Shoulder Outcome Score: SF-12

    Time frame: Preop, 1 year post/op

    The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.

  4. Post Operative Pain Score (Visual Analog Scale)

    Time frame: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

    Pain scale from 0 (no pain) - 10 (worst)

  5. Range of Motion - Forward Flexion

    Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

    Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

  6. Range of Motion - Abduction

    Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year

    Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

  7. Range of Motion - External Rotation at Side

    Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year

    Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

  8. Range of Motion - External Rotation at 90 Degrees Abduction

    Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year

    Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes After Arthroscopic Rotator Cuff Repair

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2015
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.