Pain Medication After Ambulatory Surgery

NCT ID: NCT03135470

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2020-02-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Medication Adherence Adverse Drug Event

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Current practice group

All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noora Skants

MD/PhD, Specialist in anesthesiology and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elina Reponen, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Senior physician, Deputy Chief of Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki University (Central) Hospital, Peijas Hospital

Vantaa, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUS235/2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pilot Trial: Postoperative Opioid-free Analgesia
NCT04254679 COMPLETED PHASE2/PHASE3
Narcotics Inpatient / Outpatient
NCT03728517 TERMINATED
Scheduled or As Needed Pain Regimen?
NCT06495632 RECRUITING PHASE4