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Monitoring Postoperative Patient-controlled Analgesia (PCA)

Primary Purpose

Postoperative Pain, Patient Controlled Analgesia, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Smith medical CADDsolis
Sponsored by
Pether Jildenstal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pain, postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients are adult patients >17 yrs.,
  2. both men and women who has been prescribed a PCA pump for postoperative pain management and accepted participation in the study

Exclusion Criteria:

  1. Patients < 18 years old,
  2. inability to carry out the survey,
  3. neuropsychiatric or psychiatric disease,
  4. non-swedish speaking, drug abuser

Sites / Locations

  • Sahlgrenska University hospitalRecruiting
  • Sahlgrenska academy, University of GothenburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Smith medical CADDsolis

Arm Description

Using clinical routinely regime device to use and monitor postoperative controlled pain (PCA) after surgery.

This study group use a new device to use and monitor postoperative controlled pain (PCA) after surgery.

Outcomes

Primary Outcome Measures

Patients perception of involvement in their own pain regim
The patients will answer 24 Questions involving their perception of involvement in their own pain regim. Nominal scale, 0-10 worse= 0 best10. The scale will measure experience.

Secondary Outcome Measures

Nurses perception of patient safety
The nurses will answer 6 Questions involving how the PCA method influence their work regarding patient safety and their own working environment, the nominal scale will be used, 0-10 worse= 0 best10

Full Information

First Posted
September 28, 2018
Last Updated
February 21, 2023
Sponsor
Pether Jildenstal
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03697278
Brief Title
Monitoring Postoperative Patient-controlled Analgesia (PCA)
Official Title
Can the Choice of Methods for Monitoring Postoperative Patient-controlled Analgesia (PCA) Affect Patients' Involvement in Their Own Pain Regime and Outcomes of Nurses' Working Environment?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pether Jildenstal
Collaborators
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The introduction of Acute Pain Service (APS), 1985, specialized pain management could be offered to the inpatient care. An example of this is patient-controlled analgesia (PCA), which is a technique that is used mostly after surgery. A PCA pump is an electronic pump that is prepared with pain relief medicine, usually an opioid, which is administered either epidural or intravenously. PCA pumps are programmed with medical protocols. For prevent overdose, there are blocking times between possible bolus doses and a maximum dose per hour. In a Cochrane review from 2015, PCA have shown to be more beneficial for the patient especially when it comes to patient satisfaction, compared to conventional pain relief where nurses administer pain relief on request. The authors could also demonstrate that patients experience less pain and were more satisfied with patient-controlled analgesia. However, studies have showing limitations in the ease of practice of the PCA pumps, which indicates need for further development. Today the major part of the documentation in the Swedish healthcare is computerized. Using digital systems that communicate with each other should be seen as a matter of course. Instead, a human intermediator is commonly used where documentation is performed by pencil and paper. Due to the human factor that may affect the interpretation of the information the patient safety is placed at risk. The elimination of the human intermediator could lead to a safer transfer of information. There are already studies concerning computerized PCA pumps and wireless communication by medical devices, but only studies that are conducted outside of Europe and studies with the technical aspect in focus. Studies have shown that wireless communication by medical devices in the nursing setting can provide support for prioritization and increase the patient safety. However, the field of research lacks of knowledge when it comes to the patients' and nurses' experience of using PCA pumps with wireless communication system. Due to today's research field, further studies will be needed to investigate how documentation can be safeguarded and how accessible information regarding patients' need for pain relief can be linked to prescribed treatment. This may also lead to the development of nurses' way of work with patient-controlled and epidural pain relief in the postoperative pain management.
Detailed Description
Investigators will conduct a prospective intervention study including both nurses and patients in the study group. A web-based questionnaire will be used to collect the data from the participators. Inclusion criteria for the study group consisting of nurses will be registered nurses working in one of the two surgical wards included in the study. The nurses shall also have education and experience of working with PCA pumps and accepted participation in the study. Exclusion criteria for the nurses' group are lack of education and experience in working with PCA pumps and lack of basic knowledge in English. Inclusion criteria for patients are adult patients over 17 yrs., both men and women who has been prescribed a PCA pump for postoperative pain management and accepted participation in the study. Exclusion criteria for the patient group are patients under 18 yrs., old, inability to carry out the survey, neuropsychiatric or psychiatric disease, non-Swedish speaking and drug abuser. Both of the wards included in the study uses PCA pump, , Smiths medical modell CADD Solis. Only one of the wards will use the wireless monitoring platform, , Smiths medical modell CADD Solis. Intervention group; ward with PCA pumps using the wireless monitoring platform. Control group; ward using regularly PCA pumps. The patients' survey includes questions regarding satisfaction, participation and user-friendliness of the PCA pump. Patients will fill in the survey after completion of PCA treatment. Investigators intend to investigate if there is any difference in time of treatment between the intervention- and control group and if there is an ability to individualize patients' pain relief based on improved monitoring as well as the possibility of follow-up and quality work. The nurses' survey includes questions regarding the experience of monitoring and documentation work regarding PCA treatment. Nurses will fill in a questionnaire consisting of 6 questions after each work shift where they have treated one or more patient(s) with a PCA pump. Data analysis will take place in a computer program for statistical analysis. All data collected during the course of the study will be unidentified and the result will be presented at group level without the risk of tracking data to one individual. Statistics The study population size is based on a p-value 0.05 for statistical significance and 80 % power analysis, which generates need for at least 39 participants in each group. With an estimated 10 % non-response rate, investigators need 45 participants in each group consisting in a total of 90 patients. The estimated study time is 40 weeks depending on how many PCA pumps that will be prescribed throughout the study. The study estimates to start in November 2017. Flowchart 1: Study group patient Question about study participation Carried out at the preoperative surgery department alternatively at postoperative ward Elective surgery with prescripiton of PCA pumps postoperatively, exclusion criteria: Patients younger than 18 years old, inability to carry out the survey, neuropsychiatric or psychiatric disease, non-swedish speaking, drug abuser Written consent obtained either preoperatively or postoperatively Group assignment depending on postoperative ward Group 1 (Intervention group) Group 2 (Control group) PCA pump and wireless monitoring PCA pump according to current monitoring routine PCA treatment startup in either the postoperative recovery room or at the ward Approximately 2-3 days of PCA treatment Patient survey is filled in when PCA treatment is completed Flow chart 2: Study group nurses Question about study participation Meeting with information prior to study startup Nurses at the postoperative recovery room and nurses at the two surgical wards assigned for group 1 and group 2, exclusion criteria: No education/experience in working with PCA pumps, lack of basic knowledge in English Written consent obtained before study start Group allocation depending on work place/ward Group 1 (Intervention group) Group 2 (Control group) PCA pump + wireless monitoring PCA pump according to current monitoring routine Exposure time approximately 40 weeks Nurses fill in the survey consisting of 6 questions after each work shift where they have treated one or more patient(s) with a PCA pump

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Patient Controlled Analgesia, Surgery, Nurse-Patient Relations
Keywords
pain, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Using clinical routinely regime device to use and monitor postoperative controlled pain (PCA) after surgery.
Arm Title
Smith medical CADDsolis
Arm Type
Experimental
Arm Description
This study group use a new device to use and monitor postoperative controlled pain (PCA) after surgery.
Intervention Type
Device
Intervention Name(s)
Smith medical CADDsolis
Other Intervention Name(s)
intervention group
Intervention Description
This group will be monitoring from a network.
Primary Outcome Measure Information:
Title
Patients perception of involvement in their own pain regim
Description
The patients will answer 24 Questions involving their perception of involvement in their own pain regim. Nominal scale, 0-10 worse= 0 best10. The scale will measure experience.
Time Frame
Up to 15 months
Secondary Outcome Measure Information:
Title
Nurses perception of patient safety
Description
The nurses will answer 6 Questions involving how the PCA method influence their work regarding patient safety and their own working environment, the nominal scale will be used, 0-10 worse= 0 best10
Time Frame
Up to 15 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are adult patients >17 yrs., both men and women who has been prescribed a PCA pump for postoperative pain management and accepted participation in the study Exclusion Criteria: Patients < 18 years old, inability to carry out the survey, neuropsychiatric or psychiatric disease, non-swedish speaking, drug abuser
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pether Jildenstål, PhD/ass professor
Phone
00317866044
Email
pether.jildenstal@gul.se
Facility Information:
Facility Name
Sahlgrenska University hospital
City
Gothenburg
ZIP/Postal Code
41310
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pether Jildenstål, PhD/ass prof.
Phone
0046317866044
Email
pether.jildenstal@gu.se
Facility Name
Sahlgrenska academy, University of Gothenburg
City
Gothenburg
ZIP/Postal Code
Box 457 405 30 Göteborg
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Monitoring Postoperative Patient-controlled Analgesia (PCA)

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