Postoperative PainNCT02389907
Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care
An observational study of Postoperative Pain, run by The Medicines Company at 9 sites in United States.
Trial summary
Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2015to Aug 2015
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Henry Ford Health System
Detroit, Michigan, 48202
Baylor Health Research Institute
Fort Worth, Texas, 76104
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Jupiter Medical Center
Jupiter, Florida, 33458
Drexel University
Philadelphia, Pennsylvania, 19104
Magee-Women's Hospital (UPMC)
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Phoenix Clinical Research LLC
Tamarac, Florida, 33321
About this study
Official title: Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care
Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.
Read the detailed 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.
- Conditions
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Replacement Group | Adults who have undergone a total hip replacement | |
| Hysterectomy Group | Adults who have undergone a hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours - 14 days post discharge
Secondary outcomes (1)
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
Measured: 14 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: The study was not developed due to the cessation of IONSYS marketing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Abraham, MSPT, MBA, Study director, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389907
- Sponsor's protocol ID
- MDCO-ERA-14-01
- Status last verified
- Apr 2018
- First submitted
- 2 Mar 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
PubMed 19565683Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care
- ClinicalTrials.gov ID
- NCT02389907
- Acronym / sponsor ID
- MDCO-ERA-14-01
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was not developed due to the cessation of IONSYS marketing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Replacement Group | – | –Adults who have undergone a total hip replacement |
| Hysterectomy Group | – | –Adults who have undergone a hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)
Time frame: 24 hours - 14 days post discharge
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
1 secondary outcome
Post-Operative Pain Management Modality
Time frame: 14 days post discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Results publication: PubMed 19565683Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
- Results publicationCohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Abraham, MSPT, MBA study director
The Medicines Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by The Medicines Company at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.