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

The Medicines Company

Status: Withdrawn

Conditions: Postoperative Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT02389907

MDCO-ERA-14-01

Details and patient eligibility

About

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

Full description

A study to assess the association between patients' perceptions of success with post-operative pain management following total hip replacement or hysterectomy surgery and their later perception of pain management while in the hospital and the hospital overall.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

0 participants in 2 patient groups

Total Hip Replacement Group

Description:

Adults who have undergone a total hip replacement

Hysterectomy Group

Description:

Adults who have undergone a hysterectomy