Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care

Withdrawn before enrolling

Conditions studied: Postoperative Pain

In brief

Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.

Key facts

Study ID: NCT02389907
Run by: The Medicines Company
People needed: 0
Starts: 2015-06-01
Expected to finish: 2015-08-01
Last updated by the study team: 2018-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be 18 years of age or older
Subject (or their legally acceptable representative) must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Subject is receiving a unilateral total hip replacement or a hysterectomy (total abdominal hysterectomy, total abdominal hysterectomy/bilateral salpingo-oophorectomy, total vaginal hysterectomy, or total vaginal hysterectomy/salpingo-oophorectomy)
Subject is expected to remain hospitalized for at least 24 hours post-operatively
Subject is expected to experience pain requiring IV PCA or non-PCA (non-patient controlled opioids via IV, IM, SC, or PO routes of administration) opioids for at least 24 hours after surgery
Subject is classified as American Society of Anesthesiology (ASA) category I, II, or III
Subject is willing to complete the required post-operative survey measures to be completed in the hospital
Subject is willing to complete a post-discharge survey (including HCAHPS survey instrument) via telephone approximately two-weeks (14 days) post-discharge

You may not qualify if…

Subject is having an operation other than the surgical procedures selected for inclusion (e.g., bilateral or partial hip replacement, or hip revision)
Subject cannot read, write, and communicate in English
Subject has a history of tolerance to opioids including those prescribed opioids in the 3 month period leading up to the perioperative period (i.e., a subject is considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery they have been taking a short acting/short acting combination opioid analgesic greater than 120 mg codein daily, 40 mg hydrocodone daily, 200 mg tramadol daily, or 40 mg oxycodone daily or if they were on any dose of strong opioid analgesic such as morphine, hydromorphone, or fentanyl)
Subject has a history of allergy to opioids reported pre-operatively or documented in medical history
Subject is scheduled to receive additional surgical procedures beyond those listed within 72 hours of the initial surgery

Where it is running

Bridgeport Hospital — Bridgeport, Connecticut, United States
Jupiter Medical Center — Jupiter, Florida, United States
Phoenix Clinical Research LLC — Tamarac, Florida, United States
Henry Ford Health System — Detroit, Michigan, United States
Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
Drexel University — Philadelphia, Pennsylvania, United States
Magee-Women's Hospital (UPMC) — Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Baylor Health Research Institute — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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