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

NCT02389907 | Withdrawn

• 1 other identifier: MDCO-ERA-14-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-Operative Pain Management Modality

  14 days post discharge

Other Outcomes (1)

• Composite outcome measures consisting of multiple measures

  48 Hours Post Op

Study Arms (2)

Total Hip Replacement Group

Adults who have undergone a total hip replacement

Hysterectomy Group

Adults who have undergone a hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.

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 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

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (9)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Phoenix Clinical Research LLC

Tamarac, Florida, 33321, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Women's Hospital (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Baylor Health Research Institute

Fort Worth, Texas, 76104, United States

Location

Related Publications (2)

• Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

  PMID: 19565683 RESULT

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

  RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jeffrey Abraham, MSPT, MBA

  The Medicines Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (9)