Postoperative PainNCT03697278
Monitoring Postoperative Patient-controlled Analgesia (PCA)
A study testing Smith medical CADDsolis in people with Postoperative Pain and Patient Controlled Analgesia, run by Pether Jildenstal at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Patient Controlled Analgesia, Surgery
- What is being tested?
- Smith medical CADDsolis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 28 Sep 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients < 18 years old,
- inability to carry out the survey,
- neuropsychiatric or psychiatric disease,
- non-swedish speaking, drug abuser
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University hospital
Gothenburg, 41310
Sahlgrenska academy, University of Gothenburg
Gothenburg, Box 457 405 30 Göteborg
About this study
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?
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.
Read more
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.
Read the 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
- Being tested
- Smith medical CADDsolis
- Keywords
- pain, postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smith medical CADDsolisDevice
Also called intervention group
This group will be monitoring from a network.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Using clinical routinely regime device to use and monitor postoperative controlled pain (PCA) after surgery. |
| Smith medical CADDsolis | Experimental | This study group use a new device to use and monitor postoperative controlled pain (PCA) after surgery. Receives: Device: Smith medical CADDsolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 months
Secondary outcomes (1)
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
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start28 Sep 2018
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pether Jildenstal
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor-investigator, Pether Jildenstal, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697278
- Sponsor's protocol ID
- 293-17
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2018
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03697278
- Acronym / sponsor ID
- 293-17
- Keywords
- pain, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pether JildenstalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Using clinical routinely regime device to use and monitor postoperative controlled pain (PCA) after surgery. |
| Smith medical CADDsolis | Experimental | Device: Smith medical CADDsolisThis study group use a new device to use and monitor postoperative controlled pain (PCA) after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients < 18 years old,
- inability to carry out the survey,
- neuropsychiatric or psychiatric disease,
- non-swedish speaking, drug abuser
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smith medical CADDsolisAlso: intervention groupThis group will be monitoring from a network. | Device | Smith medical CADDsolis |
Primary outcome
Patients perception of involvement in their own pain regim
Time frame: Up to 15 months
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.
1 secondary outcome
Nurses perception of patient safety
Time frame: Up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smith medical CADDsolis in people with Postoperative Pain and Patient Controlled Analgesia, run by Pether Jildenstal at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients perception of involvement in their own pain regim (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.