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

Postoperative Pain Clinical Trial

Official title:

Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02389907
• Other study ID #: MDCO-ERA-14-01
• Status: Withdrawn
• First received: March 2, 2015
• Last updated: April 24, 2018
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Henry Ford Health System	Detroit	Michigan
United States	Baylor Health Research Institute	Fort Worth	Texas
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Jupiter Medical Center	Jupiter	Florida
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	Phoenix Clinical Research LLC	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. — View Citation

Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite outcome measures consisting of multiple measures	Depending on available statistical power, other relevant constructs, including pain severity and mobility, as measured by BPI, a one-item Pain Numerical Rating Scale (NRS), and mobility items from the Ease of Care (EOC) Questionnaire, as well as patient demographic characteristics and medical/medication history will be taken into account when assessing the primary and secondary objectives.	48 Hours Post Op
Primary	Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)	Assess the association between patients' perceptions of success with opioid post-operative pain management following total hip replacement or hysterectomy surgery as measured by a patient global assessment (PGA) at 24 hours post-op and at 48 hours post-op, and their perception of pain management while in the hospital and the hospital overall, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) instrument two-weeks (14 days) post-discharge	24 hours - 14 days post discharge
Secondary	Post-Operative Pain Management Modality	Determine whether there are differences in patients' perception of pain management while in the hospital and the hospital overall with respect to post-operative pain management modality	14 days post discharge