Monitoring Postoperative Patient-controlled Analgesia (PCA)

NCT03697278 | Completed

• 1 other identifier: 293-17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain; Patient Controlled Analgesia; Surgery; Nurse-Patient Relations

Keywords

pain; postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 15 months

Secondary Outcomes (1)

• Nurses perception of patient safety

  Up to 15 months

Study Arms (2)

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.

Device: Smith medical CADDsolis

Interventions

Smith medical CADDsolis DEVICE

This group will be monitoring from a network.

Also known as: intervention group

Smith medical CADDsolis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients \< 18 years old,
• inability to carry out the survey,
• neuropsychiatric or psychiatric disease,
• non-swedish speaking, drug abuser

Sponsors & Collaborators

• Pether Jildenstal: lead
• Göteborg University: collaborator

Study Sites (2)

Sahlgrenska University hospital

Gothenburg, 41310, Sweden

Location

Sahlgrenska academy, University of Gothenburg

Gothenburg, Box 457 405 30 Göteborg, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior lecturer PhD

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 5, 2018
• Study Start: September 28, 2018
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

SE (2)