The difference between the documented and perceived adherence to the pain management protocol in patients undergoing lower limb amputation
| ISRCTN | ISRCTN19372511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19372511 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 201900820 |
| Sponsor | University Medical Center Groningen |
| Funder | Universitair Medisch Centrum Groningen |
- Submission date
- 17/01/2021
- Registration date
- 09/02/2021
- Last edited
- 05/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
In the Netherlands, approximately 3,300 lower limb amputations are performed annually. An amputation is a major intervention, which is associated with severe postoperative pain. Chronic postsurgical pain is only partly understood, difficult to treat and the effectiveness of treatment is limited. The severity and duration acute postoperative pain is associated with the risk of chronic pain. Preventive treatment should take place in the preoperative, intraoperative and in the first week of the postoperative phase with the aim of preventing long-term sensitization of the spine by blocking or modulating the nociceptive input after peripheral nerve damage. A perioperative pain management protocol for amputation has been introduced in the UMCG. This protocol describes the items and associated interventions of pain management that should be performed during the perioperative period of amputation. This protocol should be followed unless there are contra-indications in specific parts of the protocol.
The study aims to discover how this protocol was followed by patients.
Who can participate?
Patients who underwent amputation of the lower limb at the University Medical Center Groningen (Netherlands) (June 28, 2017 - February 1, 2020)
What does the study involve?
All patient records were analyzed to determine adherence to the perioperative pain management protocol (PPMP). To identify the perceived adherence to the PPMP a survey was also conducted among involved physicians.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University Medical Center Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
December 2019 to October 2020
Who is funding the study?
University Medical Center Groningen (Netherlands)
Who is the main contact?
Prof André P. Wolff, a.p.wolff@umcg.nl
Contact information
Public
Department of Anaesthesiology, UMCG Pain Center
Location Beatrixoord Dilgtweg 5
Haren
9750 RA
Netherlands
 ORCID ID |
0000-0001-6240-3903 |
|---|---|
| Phone | +31 503612140 |
| a.p.wolff@umcg.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospecitve observational study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Discrepancy between the documented and perceived adherence to the perioperative pain management protocol in patients undergoing lower limb amputation. A retrospective observational study |
| Study objectives | The adherence to the perioperative pain management protocol in patients who underwent a lower limb amputation is high |
| Ethics approval(s) | Approved 10/12/2019, University Medical Center Groningen Institutional Review Board (PO Box 30 001, 9700 RB, Groningen, The Netherlands; +31 503614204; metc@umcg.nl), ref: METc 201900820 |
| Health condition(s) or problem(s) studied | Patients who underwent a lower limb amputation |
| Intervention | Between June 1, 2017 and February 29, 2020, 153 lower limb amputations were performed. All patient records were analyzed retrospectively to determine the documented adherence to the perioperative pain management protocol (PPMP). To identify the perceived adherence to the PPMP a survey was also conducted among involved physicians. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Documented adherence by patients to the perioperative pain management protocol measured from patient records by the researchers using a newly developed set of 11 adherence criterias at a single time point |
| Key secondary outcome measure(s) |
Patient characteristics measured using patient records at a single time point: |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 123 |
| Total final enrolment | 123 |
| Key inclusion criteria | 1. Patients who underwent transfemoral amputation, knee disarticulation, transtibial- and (partial) foot amputations, and whose data were registered in EPIC 2. Interns and residents in vascular surgery, vascular surgeons, residents in anaesthesiology and anaesthesiologists involved in the amputation process |
| Key exclusion criteria | 1. Patients younger than 18 years 2. Patients who underwent a toe amputation or a stump revision 3. Physician is no longer working in the hospital |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 01/02/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Location Beatrixoord Dilgtweg 5
Haren
9750 RA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/04/2022: The intention to publish date was changed from 01/10/2021 to 31/12/2022.
09/02/2021: Internal review.
20/01/2021: Trial’s existence confirmed by University Medical Center Groningen
