We aim to investigate the effectiveness of implementation of a TPS compared to standard of care (SOC) for patients at risk of developing CPSP, as measured by quality of recovery, incidence of CPSP and opioid consumption.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the between group difference in Quality of Recovery
(QoR)-15 questionnaire score at day three after surgery.
Secondary outcome
Secondary outcomes are the incidence of CPSP, opioid consumption and
patient-reported outcome measures.
Background summary
Patients with either surgery or patient-related risk factors (e.g. pre-existing
chronic pain or preoperative opioid consumption) are at an increased risk of
acute and chronic postsurgical pain (CPSP) and long-term opioid use. To improve
recovery, prevent CPSP and decrease opioid use, we need to identify these
patients before surgery and provide a multidisciplinary pain management
strategy throughout hospital admission and follow up in the post discharge
period. Randomized trials assessing the impact of a multidisciplinary
transitional pain service (TPS) on quality of recovery, incidence of CPSP and
opioid consumption have not been conducted yet and is the purpose of this
study.
Study objective
We aim to investigate the effectiveness of implementation of a TPS compared to
standard of care (SOC) for patients at risk of developing CPSP, as measured by
quality of recovery, incidence of CPSP and opioid consumption.
Study design
Pragmatic, open label, randomized controlled trial.
Intervention
Patients will be randomized to the TPS group or SOC group. Patients allocated
to the SOC group will receive a pre-assessment at the outpatient preoperative
evaluation (OPE) clinic. Postoperative pain will be managed per protocol by the
Acute Pain Service (APS) for patients with epidural analgesia, peripheral nerve
catheter or using patient controlled analgesia (PCA). When the APS is not
involved, postoperative pain will be managed by the surgeon and/or nurses on
the ward.
In the TPS group, the multidisciplinary TPS team, consisting of
anesthesiologists and nurses who are specialized in pain, will make an
individualized perioperative pain management plan. If necessary, referrals to a
psychologist, physiotherapist or social worker will be made. After surgery, the
APS, supervised by a member of the TPS team, will perform daily visits to
monitor the effectiveness of pain treatment and to cease any medication that is
deemed unnecessary. Following discharge from the hospital, the General
Practitioner will be provided with information on the further pain treatment
strategy for a better transition of care. Patients will be scheduled for
follow-up appointments at the TPS outpatient clinic, or receive follow-up
telephone calls to re-evaluate the pain treatment plan, taper opioids and if
CPSP is diagnosed, referred to a pain specialist after six months.
Study burden and risks
There are no safety risks associated with this study. Patients randomized to
TPS will receive consultations by a member of the TPS team pre-, and
postoperatively and are monitored frequently, in addition to current standard
of care. Patients will be treated according to currently accepted protocols and
guidelines. The additional burden for patients is completion of additional
questionnaires pre- and postoperative, and after discharge. This will take
approximately 20-30 minutes at four moments in six months, whereat for example
WHO-DAS 2.0 preoperatively is already standard procedure. Possible benefits for
patients are improvement of quality of recovery, prevention of CPSP and
avoiding unnecessary opioid prescriptions.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients aged 18 years or older
2. Willing and able to provide informed consent
3. Undergoing a surgical procedure with an increased risk of CPSP (amputation,
spinal surgery, thoracotomy, breast surgery, herniotomy, hysterectomy and after
arthroplasty) (8).
Or;
Any surgical procedure and one of the following:
- Diagnosed chronic pain, defined according to the ICD-11 as *an unpleasant
sensory and emotional experience associated with actual or potential tissue
damage, or described in terms of such damage. Chronic pain is pain that
persists or recurs for longer than 3 months (3)*
- Chronic opioid use, defined as > 20 mg daily morphine equivalent (MME)
consumption for more than 3 months in the last 3 months
- Allergy to opioid agents
- Patients with pain device implants, such as intrathecal pain pump, spinal
cord stimulation or peripheral nerve stimulator
- The usage of pain medication as methadone, buprenorphine, anticonvulsants,
antidepressants or medicinal cannabis for chronic pain for more than 3 months
in the last three months
- Psychosocial comorbidities like anxiety, depression, pain catastrophizing if
documented in the electronic medical record
Exclusion criteria
- Not willing or able to provide written informed consent
- Emergency surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74802.018.20 |