Pain Medication After Ambulatory Surgery

July 28, 2020 updated by: Noora Skants, Helsinki University Central Hospital

Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study

In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient needs, risks, adverse effects and patient's capacity to follow instructions should be assessed during the few hour visit at the clinic. In many clinics, pain is treated after hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over 2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone use after patient discharge compared to some other Finnish ambulatory surgery clinics. The aim of this study is to evaluate, whether the prescribed pain medication is sufficient and whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter interview). The study proceeds in three phases: 1) observation of current medication practice, 2) observation after optimization and standardization of hospitals drug prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.

Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.

Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vantaa, Finland, 00029
        • Helsinki University (Central) Hospital, Peijas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated as ambulatory surgery patients in our clinic (orthopaedics, urology) during 3 month study periods (three 3 month phases)

Description

Inclusion Criteria:

All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent

Exclusion Criteria:

We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Current practice group
All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period
Standard operating protocol group
All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period after creating and informing standardized operating protocol
Mobile phone app group
All plenipotentiary ambulatory surgery patients during the three month study period with informed consent to use mobile phone app in assesment of pain and pain medication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication
Time Frame: up to two days after surgery
all pain medication used (reported By the patient)
up to two days after surgery
Pain
Time Frame: up to two days after surgery
Pain assessed By the patient By numerical rating scale 0-10
up to two days after surgery
Adverse effects
Time Frame: up to two days after surgery
Adverse effects of the pain medication, study questions
up to two days after surgery
Sufficiency of pain medication
Time Frame: up to two days after surgery
Whether the pain medication used was sufficient or not, study questions
up to two days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elina Reponen, MD/PhD, Senior physician, Deputy Chief of Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUS235/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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