Tamarac, Florida 33321

  • Postoperative Pain

Purpose:

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


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

MDCO-ERA-14-01


NCT ID:

NCT02389907


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Medicines Company


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

The study was not developed due to the cessa


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey Abraham, MSPT, MBA
Study Director
The Medicines Company

Study Dates

Start Date:June 2015
Completion Date:August 2015
Completion Type:Anticipated
Primary Completion Date:August 2015
Primary Completion Type:Anticipated
Verification Date:April 2018
Last Changed Date:April 24, 2018
First Received Date:March 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Post-Operative Pain Management Modality
Time Frame:14 days post discharge
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)
Time Frame:24 hours - 14 days post discharge
Safety Issues:False
Description: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

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Hysterectomy Group
Description:Adults who have undergone a hysterectomy
Study Arm Type:Other
Arm Name:Total Hip Replacement Group
Description:Adults who have undergone a total hip replacement

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The Medicines Company

Samples and Retentions

Study Population: Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation:Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.
Reference Type:Results Reference
Citation:Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9.
PMID:19565683

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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