Pain, PostoperativeNCT03439566
Does Preoperative Pain Levels by Venipuncture Predict Late Postoperative Pain Levels?
An observational study of Pain, Postoperative, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
This study wishes to investigate if pain by peripheral venous cannulation (PVC) preoperatively, will predict pain levels after 24 h postoperatively. Furthermore, to investigate moderate/severe pain at the postoperatively at the post-anaesthesia care unit (PACU) is associated with increased late (24h) pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2018to 1 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total hip arthroplasty (THA) at Zealand University Hospital, Koege meeting the inclusion criteria
Who may be able to join
- Patients undergoing total hip arthroplasty in spinal anaesthesia
- Patients who understand and speak Danish or English
Who cannot join
- Patients who cannot cooperate with the study
- Alcohol and drug dependency as judged by the investigator
- Patients in need of urgent surgery
- Patients whom first Peripheral Venous Cannulation attempt was unsuccessful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Preoperative Pain Levels by Venipuncture Predict Late Postoperative Pain Levels? - a Prospective Cohort Study of Total Hip Arthroplasty Patients at Zealand University Hospital, Koege
This study wishes to investigate if pain by peripheral venous cannulation (PVC) preoperatively, will predict pain levels after 24 h postoperatively. Furthermore, to investigate moderate/severe pain at the postoperatively at the post-anaesthesia care unit (PACU) is associated with increased late (24h) pain. Additionally, if the PACU nurse is able to predict if the patient will be a high pain responder, by using a clinical judgement. Finally to evaluate the patient's pain-levels at home after discharge and investigate for associations between postoperative pain and post-discharge pain.
Read the detailed description
Postoperative pain remains insufficiently treated in clinically relevant proportions of patients across procedures, but with varying incidences. Preoperative identification of patients at risk for increased postoperative pain may result in stratification of perioperative analgesic protocols, aiming at reducing pain in high-risk patients while avoiding over-treatment in those at low-risk.
Several potential patient-related factors have been suggested as associated with an increased risk of higher postoperative pain levels. Studies indicate a positive correlation between postoperative pain levels and e.g. preoperative pain levels, gender, age and socioeconomically and psychological variables. The Pain Catastrophizing Scale (PCS), has been used to look for associations between psychological variables and levels of early and late pain as well. However, no firm data exist for a clinically useful identification of individual high pain responders.
Preoperative sensory testing of patient's nociception has the potential to predict postoperative pain levels. However, a review dealing with the prediction of postoperative pain based on experimental pain studies demonstrated that quantitative sensory testing was only able to predict 4 - 54% of the variance of the postoperative pain of individual patients. Another recent study of clinically applicable tests suggested that relevant sensitivity and specificity can be achieved, but this has not been translated into clinical practice or confirmed. Thus, no preoperative testing method has proven clinically relevant or useful until now.
A newer pragmatic clinical study indicated that the pain intensity associated with peripheral venous cannulation (PVC) could be used as a simple predictor of the magnitude of early pain levels at one hour postoperatively at the post-anaesthesia care unit (PACU). That study, however, did not test the possible association between venepuncture related pain and later pain levels at 24h.
Another simple method for early identification of those with an intensified need of pain treatment after PACU discharge could be to investigate if higher pain levels early postoperatively at the PACU are associated with higher levels of late postoperative pain. Especially, we find it relevant at the individual patient level to investigate if NRS below 3 (moderate/severe pain) in the early postoperative phase at the PACU is associated with NRS levels above 3 late postoperatively.
Also, it could be relevant to investigate if the PACU-nurses, based on their clinical evaluation, are able to predict if the patient would experience an increased risk of moderate/severe pain after PACU discharge. Such a simple clinical tool of staff's judgement of risk of postoperative pain levels has never been tested before.
The hypothesis is that levels of early and late pain are associated and with a simple clinical related tool it could be possible to identify patients with increased pain levels at 24-hours postoperatively.
With updated fast-track perioperative patient causes, patients often are discharged quickly after the surgical procedure. Often there may be a lack of knowledge on how they manage to return to daily living. Pain can be a major problem for the patients, possibly also at home.
Even though one cannot be certain that patients with severe pain, will contact the hospital after discharge. Not only can pain delay rehabilitation it can also be a major factor for developing chronic pain.
Therefore, it is relevant to monitor the patient's pain-levels, quality of sleep, mood, as well as analgesic use and side-effects at home, using a diary from discharge until 5 days postoperatively. Especially, to investigate if patients with higher postoperative pain levels also experience excess pain-related problems after discharge.
.
- Conditions
- Pain, Postoperative
- Keywords
- pain measures, prediction of pain, pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total hip arthroplasty | No intervention will take place. Only registration and data collection of patient´s care and treatment will take place. There will be no changes in patient´s treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups, in levels of pain (NRS < / > 2) by peripheral venous cannulation (PVC) preoperatively, during mobilisation at 24 hour postoperatively
The patients will be divided in two groups when the peripheral venous cannula is placed Group 1 is patients with a NRS pain below 2. Group 2 is patients with NRS levels above 2. Is there a correlation between the groups when looking at the NRS levels at rest after the spinal has ceased and at 24h mobilisation postoperatively
Measured: Preoperatively just before the patient will be sedated and 24h postoperatively
Secondary outcomes (4)
Difference between groups, defined by levels of pain by peripheral venous cannulation (PVC) preoperatively (NRS < / > 2) at rest, after spinal has ceased (Bromage=0-1), at 24 h postoperatively
The patients will be divided in two groups when the PVC is placed according to NRS level Is there a correlation between the groups when looking at the NRS levels at rest after the spinal has ceased and at 24h postoperatively and opioid consumption?
Measured: Preoperatively, just before the patient will be sedated when the spinal has ceased (Bromage=0-1) at 1 to 4 h postoperatively and at 24h postoperatively
Difference between groups, defined by Post Anaesthesia Care Unit nurses´ prediction of high pain responders (yes/ no), and levels of pain at 24-hour postoperatively, at rest and during mobilisation, and 24h postoperative opioid consumption
The patients will be divided in two groups when the peripheral venous cannula is placed. Group 1 is patients with a NRS pain below 2. Group 2 is patients with NRS levels above 2. Is there a correlation between the groups and the PACU nurse´s prediction about the patient beeing a high pain responder or not and NRS levels of pain at rest and during mobilisation at 24 h postoperatively and 24 h opioid consumption.
Measured: Postoperatively at discharge from the PACU up to 4h postoperatively and 24 hours postoperatively
Difference between groups, defined by patient's experienced level of pain at rest (Numerical ranking scale < 3 / > 3) and levels of pain at rest at 24 hour postoperatively and 24-hour postoperative opioid consumption.
The patients will be divided in two groups patients with NRS pain levels below 3 and above 3. Is there a correlation between the groups when looking at the NRS levels at rest at 24h postoperatively and 24 h opioid consumption?
Measured: 24 hour postoperatively
A patient diary, investigating postoperative pain levels, sleep and mood
Pain monitored using NRS. Nausea monitored using Verbal Rating Scale (None, slightly, moderate, severe) Vomiting monitored by numbers of. Medication monitored in mg. Patients mood monitored by yes or no. Quality of sleep monitored by good sleep, difficulties sleeping, many awakenings, no sleep at all
Measured: Day 1 to 5 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start15 Jan 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Geisler, Zealand University Hospital
- Investigators
- Anja Geisler, PhD student, Principal investigator, Zealand University Hospital, Koege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439566
- Sponsor's protocol ID
- SM4-AG-17
- Status last verified
- Mar 2019
- First submitted
- 24 Nov 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geisler A, Zachodnik J, Laigaard J, Kruuse LS, Sorensen CV, Sandberg M, Persson EI, Mathiesen O. Using four different clinical tools as predictors for pain after total hip arthroplasty: a prospective cohort study. BMC Anesthesiol. 2020 Mar 3;20(1):57. doi: 10.1186/s12871-020-00959-2.
PubMed 32126971
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Pain Levels by Venipuncture Predict Late Postoperative Pain Levels? - a Prospective Cohort Study of Total Hip Arthroplasty Patients at Zealand University Hospital, Koege
- ClinicalTrials.gov ID
- NCT03439566
- Acronym / sponsor ID
- SM4-AG-17
- Conditions
- Pain, Postoperative
- Keywords
- pain measures, prediction of pain, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Feb 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.
This study wishes to investigate if pain by peripheral venous cannulation (PVC) preoperatively, will predict pain levels after 24 h postoperatively. Furthermore, to investigate moderate/severe pain at the postoperatively at the post-anaesthesia care unit (PACU) is associated with increased late (24h) pain. Additionally, if the PACU nurse is able to predict if the patient will be a high pain responder, by using a clinical judgement. Finally to evaluate the patient's pain-levels at home after discharge and investigate for associations between postoperative pain and post-discharge pain.
Detailed description
Postoperative pain remains insufficiently treated in clinically relevant proportions of patients across procedures, but with varying incidences. Preoperative identification of patients at risk for increased postoperative pain may result in stratification of perioperative analgesic protocols, aiming at reducing pain in high-risk patients while avoiding over-treatment in those at low-risk.
Several potential patient-related factors have been suggested as associated with an increased risk of higher postoperative pain levels. Studies indicate a positive correlation between postoperative pain levels and e.g. preoperative pain levels, gender, age and socioeconomically and psychological variables. The Pain Catastrophizing Scale (PCS), has been used to look for associations between psychological variables and levels of early and late pain as well. However, no firm data exist for a clinically useful identification of individual high pain responders.
Preoperative sensory testing of patient's nociception has the potential to predict postoperative pain levels. However, a review dealing with the prediction of postoperative pain based on experimental pain studies demonstrated that quantitative sensory testing was only able to predict 4 - 54% of the variance of the postoperative pain of individual patients. Another recent study of clinically applicable tests suggested that relevant sensitivity and specificity can be achieved, but this has not been translated into clinical practice or confirmed. Thus, no preoperative testing method has proven clinically relevant or useful until now.
A newer pragmatic clinical study indicated that the pain intensity associated with peripheral venous cannulation (PVC) could be used as a simple predictor of the magnitude of early pain levels at one hour postoperatively at the post-anaesthesia care unit (PACU). That study, however, did not test the possible association between venepuncture related pain and later pain levels at 24h.
Another simple method for early identification of those with an intensified need of pain treatment after PACU discharge could be to investigate if higher pain levels early postoperatively at the PACU are associated with higher levels of late postoperative pain. Especially, we find it relevant at the individual patient level to investigate if NRS below 3 (moderate/severe pain) in the early postoperative phase at the PACU is associated with NRS levels above 3 late postoperatively.
Also, it could be relevant to investigate if the PACU-nurses, based on their clinical evaluation, are able to predict if the patient would experience an increased risk of moderate/severe pain after PACU discharge. Such a simple clinical tool of staff's judgement of risk of postoperative pain levels has never been tested before.
The hypothesis is that levels of early and late pain are associated and with a simple clinical related tool it could be possible to identify patients with increased pain levels at 24-hours postoperatively.
With updated fast-track perioperative patient causes, patients often are discharged quickly after the surgical procedure. Often there may be a lack of knowledge on how they manage to return to daily living. Pain can be a major problem for the patients, possibly also at home.
Even though one cannot be certain that patients with severe pain, will contact the hospital after discharge. Not only can pain delay rehabilitation it can also be a major factor for developing chronic pain.
Therefore, it is relevant to monitor the patient's pain-levels, quality of sleep, mood, as well as analgesic use and side-effects at home, using a diary from discharge until 5 days postoperatively. Especially, to investigate if patients with higher postoperative pain levels also experience excess pain-related problems after discharge.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total hip arthroplasty | – | –No intervention will take place. Only registration and data collection of patient´s care and treatment will take place. There will be no changes in patient´s treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip arthroplasty (THA) at Zealand University Hospital, Koege meeting the inclusion criteria
Key inclusion criteria (2 listed)
- Patients undergoing total hip arthroplasty in spinal anaesthesia
- Patients who understand and speak Danish or English
Key exclusion criteria (4 listed)
- Patients who cannot cooperate with the study
- Alcohol and drug dependency as judged by the investigator
- Patients in need of urgent surgery
- Patients whom first Peripheral Venous Cannulation attempt was unsuccessful
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between groups, in levels of pain (NRS < / > 2) by peripheral venous cannulation (PVC) preoperatively, during mobilisation at 24 hour postoperatively
Time frame: Preoperatively just before the patient will be sedated and 24h postoperatively
The patients will be divided in two groups when the peripheral venous cannula is placed Group 1 is patients with a NRS pain below 2. Group 2 is patients with NRS levels above 2. Is there a correlation between the groups when looking at the NRS levels at rest after the spinal has ceased and at 24h mobilisation postoperatively
4 secondary outcomes
Difference between groups, defined by levels of pain by peripheral venous cannulation (PVC) preoperatively (NRS < / > 2) at rest, after spinal has ceased (Bromage=0-1), at 24 h postoperatively
Time frame: Preoperatively, just before the patient will be sedated when the spinal has ceased (Bromage=0-1) at 1 to 4 h postoperatively and at 24h postoperatively
Difference between groups, defined by Post Anaesthesia Care Unit nurses´ prediction of high pain responders (yes/ no), and levels of pain at 24-hour postoperatively, at rest and during mobilisation, and 24h postoperative opioid consumption
Time frame: Postoperatively at discharge from the PACU up to 4h postoperatively and 24 hours postoperatively
Difference between groups, defined by patient's experienced level of pain at rest (Numerical ranking scale < 3 / > 3) and levels of pain at rest at 24 hour postoperatively and 24-hour postoperative opioid consumption.
Time frame: 24 hour postoperatively
A patient diary, investigating postoperative pain levels, sleep and mood
Time frame: Day 1 to 5 postoperatively
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 28 Mar 2019.
- Derived from this study: PubMed 32126971Geisler A, Zachodnik J, Laigaard J, Kruuse LS, Sorensen CV, Sandberg M, Persson EI, Mathiesen O. Using four different clinical tools as predictors for pain after total hip arthroplasty: a prospective cohort study. BMC Anesthesiol. 2020 Mar 3;20(1):57. doi: 10.1186/s12871-020-00959-2.
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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.
Anja Geisler, PhD student principal investigator
Zealand University Hospital, Koege
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 Pain, Postoperative, run by Zealand University Hospital at 1 site in Denmark.
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 28 Mar 2019. 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 Denmark. 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?
Difference between groups, in levels of pain (NRS < / > 2) by peripheral venous cannulation (PVC) preoperatively, during mobilisation at 24 hour postoperatively (time frame: Preoperatively just before the patient will be sedated and 24h postoperatively). 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 NCT03439566, which also lists 1 linked publication.
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 28 Mar 2019.