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OpenTrials
Completed

NCT Number: NCT03967847

Oral Ketorolac for Arthroscopic Rotator Cuff Repair

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair. 2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.

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Key information

Conditions

Rotator Cuff Tear Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between the ages of 18 and 89 years old, male or female
  • Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion criteria

  • Patients below the age of 18 or above the age of 89
  • Illiterate or non-English speaking patients
  • Patients with contraindications to Ketorolac
  • History of alcohol of drug abuse
  • Chronic use of analgesic or psychotropic drugs
  • Known peptic ulcer disease or bleeding diathesis
  • Renal dysfunction

Treatment and study plan

Ketorolac

Drug

Oral Ketorolac

Primary outcomes

  1. Postoperative Visual Analog Scale Scores

    Time frame: participants were assessed at one single time point up to 8 weeks.

    The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.

Secondary outcomes

  1. Number of Participants With Retear of Rotator Cuff Repair

    Time frame: 6 months

    Assessing retear of rotator cuff repair on postop MRI.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 30, 2019
Registry last updated
May 10, 2022

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.

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