Pain Medication After Ambulatory Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03135470
• Other study ID #: HUS235/2017
• Status: Terminated
• Start date: April 3, 2017
• Est. completion date: February 11, 2020

Study information

• Verified date: July 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions
• Medication Adherence
• Pain, Postoperative

Locations

Country	Name	City	State
Finland	Helsinki University (Central) Hospital, Peijas Hospital	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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