Pain Medication After Ambulatory Surgery

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: Terminated
• Conditions: Pain, Postoperative; Medication Adherence; Adverse Drug Event

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: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Medication	all pain medication used (reported By the patient)	up to two days after surgery
Pain	Pain assessed By the patient By numerical rating scale 0-10	up to two days after surgery
Adverse effects	Adverse effects of the pain medication, study questions	up to two days after surgery
Sufficiency of pain medication	Whether the pain medication used was sufficient or not, study questions	up to two days after surgery

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Elina Reponen, MD/PhD, Senior physician, Deputy Chief of Department

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): February 11, 2020

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pain; oxycodone; ambulatory surgery; adverse effect
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Drug-Related Side Effects and Adverse Reactions
• Other Study ID 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