No registrations found.
Source
Brief title
Health condition
Postoperative pain
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The main study endpoint is the description of the psychometric properties of the optimized Dutch OBAS.
Secondary outcome
Secondary endpoints are determination of the MCID and clinical usability
Background summary
Rationale:
The ‘Overall Benefit of Analgesic Score’ (OBAS) is a sophisticated questionnaire that offers a wide perspective on the balance between postoperative pain intensity and opioid-related side effects. Its questions concern pain, satisfaction about the pain treatment, and common side effects of opioids. The OBAS was developed as a practical, easy to implement tool and was adopted in patient care at Amsterdam UMC, location AMC, shortly after the original publication. Despite being widely used, questions remain over its usability in clinical practice and the selection of included side effects. Additionally, the OBAS has not been formally translated and validated in Dutch, and the minimal clinically important difference (MCID) has not yet been determined.
This study aims to describe the usability in clinical practice of the validated Dutch translation of the optimized OBAS. Further, the MCID will be determined for application of the OBAS in later clinical trials.
Objectives:
The objectives of this study are to describe the translation, optimization and validation of the Dutch OBAS, and subsequently evaluate its usability in clinical practice. Additionally, the MCID will be determined.
Study design:
Single center prospective cohort study.
Study population:
The study population will consist of adult patients who are fluent in Dutch and have undergone elective moderate to severely painful surgery that required overnight hospitalization. A minimum of 250 research subjects are included in this study.
Main study endpoints:
The main endpoint in this study is the description of the psychometric properties of the optimized Dutch OBAS. Intra- and interrater reliability will be tested, as well as internal consistency. Further, the MCID will be determined and usability in clinical practice described.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study offers no benefits for research subjects and is not associated with additional risk. Study participation will not interfere with or change normal care and no additional visits are scheduled.
Study objective
This study aims to describe the usability in clinical practice of the validated Dutch translation of the optimized OBAS. Further, the MCID will be determined for application of the OBAS in later clinical trials.
Study design
Postoperative day 1 and 3
Inclusion criteria
- Aged eighteen years or older
- Fluent in Dutch
- Capable of completing the OBAS questionnaire
- Has no objection to study inclusion
- Underwent elective surgery that required overnight hospitalization
- The performed surgery was orthopedic, trauma surgical, neurosurgical, abdominal or obstetric in nature
Exclusion criteria
- ASA 5 or higher
- Emergency surgery
- Hospitalization at the intensive care unit (ICU), or previous admission to the ICU during the same hospital admission
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9414 |
Other | METC AMC : W21-201 |