Clinical trial NCT03135470: Pain Medication After Ambulatory Surgery
Official title: Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain, Postoperative
Medication Adherence
Adverse Drug Event
Keywords: pain
ambulatory surgery
oxycodone
adverse effect
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication
timeFrame: up to two days after surgery
measure: Pain
timeFrame: up to two days after surgery
measure: Adverse effects
timeFrame: up to two days after surgery
measure: Sufficiency of pain medication
timeFrame: up to two days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Helsinki University (Central) Hospital, Peijas Hospital
Study officials:
affiliation: Senior physician, Deputy Chief of Department
name: Elina Reponen, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: