Post Surgical PainCPoPNCT06417528
Chronic Postsurgical Pain: Multivariate Prediction Model
An observational study of Post Surgical Pain and Post Operative Pain, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 1 site in Italy.
Trial summary
The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Surgical Pain, Post Operative Pain, Postoperative Pain, Chronic
- What is being tested?
- Chronic Post Surgery Pain (CPSP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2022to 14 Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing any type of elective surgery
Who may be able to join
- Adult Patients
- Patients undergoing any type of elective surgery
Who cannot join
- Patients with sensory impairments
- Patients unable to communicate
- Patients with cognitive impairments
- Patients with insufficent knowledge of the language
Trial locations and contacts
1 site in 1 country.
Alberto Noto, MD; PhD contact
About this study
The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery.
Read the detailed description
The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP.
A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation).
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.
- Being tested
- Chronic Post Surgery Pain (CPSP)
- Keywords
- Pain, Chronic Pain, Postoperative Pain, Post Operative Pain, Post Surgical Pain, Multivariate Prediction Model, Prediction Model
- Medical subject headings
- Pain, Postoperative, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Post Surgery Pain (CPSP)Procedure or surgery
The outcome variable is the presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 on the NRS scale (11-point one-dimensional pain scale) in the last three days, and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area or referred to a dermatome.
Separate prediction models will be developed using data derived from surveys conducted at the relevant time points for the development of the risk index.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Patients | Data collection will record parameters of patients undergoing surgery at four different times: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; and postoperative period (from the third month following surgery). Receives: Procedure: Chronic Post Surgery Pain (CPSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Post Surgery Pain (CPSP)
Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) in the last three days and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
Measured: 3 months
Secondary outcomes (4)
Pre operative factors
- Age
- 18-35
- 36-55
- ≥55
- Sex
- Female
- Male
- BMI
- ≤18.5 - 24.9
- 25 - 29.9
- ≥30
- Alcohol or substances of abuse (Y/N) (specify the substance)
- Previous experience of pain NRS ≥5 for 7 days (Y/N)
- Presence of chronic pathologies (Y/N) (if yes, provide the list of medications)
- Pharmacological treatments including supplements or nutraceuticals (continuous in the last 3 months) (Y/N) (if yes, provide the list of drugs)
- Chronic pain (NRS ≥3 for ≥3 months) (Y/N)
- Neuropathic pain (Y/N) (assessment using Douleur Neuropathique en 4 questions DN-4 questionnaire)
- Pain catastrophizing (Y/N) (assessment via Pain Catastrophizing Scale PCS questionnaire)
- Anxiety (Y/N) (assessment using General Anxiety Disorder-7 GAD-7 questionnaire)
- Depression (Y/N) (assessment using Beck Depression Inventory BDI-II questionnaire)
- Presence of pain in the last three days (NRS ≥3 mean pain intensity in the 24 hours) (Y/N)
Measured: 60 to 1 day before the scheduled procedure
Perioperative factors - before surgery
- Site of surgery
- Head
- Vertebral column
- Arms/legs
- Chest
- Abdomen
- Genitourinary system
- Surgical technique
- Open surgery
- Minimally invasive surgery
- Robotic surgery
- ERAS (enhanced recovery after surgery) protocol (Y/N)
- Anesthesiologic technique
- General Anesthesia
- Spinal Anesthesia
- Epidural Anesthesia
- Peripheral nerve block
- Preventive/protective analgesia (Y/N)
- Premedication (Y/N)
- OFA opioid-free anesthesia protocol (Y/N)
- Postoperative analgesic prescription (Y/N)
Measured: The day of the scheduled surgery - before the surgery
Perioperative factors - after surgery
- Pain NRS score ≥3 at the end of the surgery (Y/N)
- Presence of pain (NRS ≥5 - average value in the 24 hours) in the region of the operation at rest or during movement after surgery (Y/N)
- Analgesic prescription after surgery
- ≤12 hours of coverage
- 13-24 hours of coverage
- ≥ 24 hours of coverage
- Postoperative surgical complications (Y/N)
- Postoperative infectious complications (Y/N)
- Mobilization after surgery ≤6 hours? (Y/N)
Measured: Immediately after the surgery to 48 hours after the surgery
Post operative factors
- Pain assessment: average pain intensity assessed using a standard NRS scale (the cutoff score will be set at ≥3 mean pain intensity over the last three days ) (Y/N).
- Diagnosis of CPSP (the pain is localized in the surgical field or in the area of the lesion, projected into the innervation territory of a nerve located in this area, or referred to a dermatome) (Y/N)
- Surgical complications (Y/N)
- Infectious complications related to surgery (Y/N)
- Malignancy (Y/N)
- Neuropathic pain (Y/N) (assessed using Douleur Neuropathique in 4 questions DN-4 questionnaire)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Dec 2022
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Post Surgical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Cardia, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417528
- Sponsor's protocol ID
- CPoP
- Acronym
- CPoP
- Status last verified
- May 2024
- First submitted
- 19 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
PubMed 25844555Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
PubMed 18434337Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
PubMed 16095934Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770.
PubMed 21978149Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591.
PubMed 20528505Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.
PubMed 26241763Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of Psychosocial and Functional Impact of Chronic Pain. J Pain. 2016 Sep;17(9 Suppl):T21-49. doi: 10.1016/j.jpain.2016.02.006.
PubMed 27586830Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14.
PubMed 19010073Mathes T, Pape-Kohler C, Moerders L, Lux E, Neugebauer EAM. External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain. Pain Med. 2018 Aug 1;19(8):1674-1682. doi: 10.1093/pm/pnx242.
PubMed 29121211Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
PubMed 22337572Sangesland A, Storen C, Vaegter HB. Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery? A systematic review. Scand J Pain. 2017 Apr;15:44-52. doi: 10.1016/j.sjpain.2016.12.002. Epub 2016 Dec 19.
PubMed 28850344Siao P, Cros DP. Quantitative sensory testing. Phys Med Rehabil Clin N Am. 2003 May;14(2):261-86. doi: 10.1016/s1047-9651(02)00122-5.
PubMed 12795516Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PubMed 19672167Werner MU, Mjobo HN, Nielsen PR, Rudin A. Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0.
PubMed 20460988
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Postsurgical Pain: Multivariate Prediction Model
- ClinicalTrials.gov ID
- NCT06417528
- Acronym / sponsor ID
- CPoP / CPoP
- Keywords
- Pain, Chronic Pain, Postoperative Pain, Post Operative Pain, Post Surgical Pain, Multivariate Prediction Model, Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia IntensivaUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 16 May 2024 (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 goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery.
Detailed description
The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP.
A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation).
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery Patients | – | Procedure: Chronic Post Surgery Pain (CPSP)Data collection will record parameters of patients undergoing surgery at four different times: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; and postoperative period (from the third month following surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing any type of elective surgery
Key inclusion criteria (2 listed)
- Adult Patients
- Patients undergoing any type of elective surgery
Key exclusion criteria (4 listed)
- Patients with sensory impairments
- Patients unable to communicate
- Patients with cognitive impairments
- Patients with insufficent knowledge of the language
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 |
|---|---|---|
| Chronic Post Surgery Pain (CPSP)The outcome variable is the presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 on the NRS scale (11-point one-dimensional pain scale) in the last three days, and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area or referred to a dermatome. Separate prediction models will be developed using data derived from surveys conducted at the relevant time points for the development of the risk index. | Procedure or surgery | Surgery Patients |
Primary outcome
Chronic Post Surgery Pain (CPSP)
Time frame: 3 months
Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) in the last three days and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
4 secondary outcomes
Pre operative factors
Time frame: 60 to 1 day before the scheduled procedure
Perioperative factors - before surgery
Time frame: The day of the scheduled surgery - before the surgery
Perioperative factors - after surgery
Time frame: Immediately after the surgery to 48 hours after the surgery
Post operative factors
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 25844555Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 18434337Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
- Background: PubMed 16095934Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
- Background: PubMed 21978149Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770.
- Background: PubMed 20528505Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591.
- Background: PubMed 26241763Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.
- Background: PubMed 27586830Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of Psychosocial and Functional Impact of Chronic Pain. J Pain. 2016 Sep;17(9 Suppl):T21-49. doi: 10.1016/j.jpain.2016.02.006.
- Background: PubMed 19010073Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14.
- Background: PubMed 29121211Mathes T, Pape-Kohler C, Moerders L, Lux E, Neugebauer EAM. External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain. Pain Med. 2018 Aug 1;19(8):1674-1682. doi: 10.1093/pm/pnx242.
- Background: PubMed 22337572Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
- Background: PubMed 28850344Sangesland A, Storen C, Vaegter HB. Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery? A systematic review. Scand J Pain. 2017 Apr;15:44-52. doi: 10.1016/j.sjpain.2016.12.002. Epub 2016 Dec 19.
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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.
Alberto Noto, MD; PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Surgical Pain and Post Operative Pain, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Cardia, MD; PhD (+39 340 6946866, lcardia@unime.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Post Surgery Pain (CPSP) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417528, which also lists 33 linked publications.
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 May 2024.