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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Zealand University Hospital, Koege

    Copenhagen, Køge, 4600

Other trials in Denmark

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.

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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 groups in NCT03439566
Study groupRoleWhat they receive
Total hip arthroplastyNo 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted20 Feb 2018
  2. Study start15 Jan 2018
  3. Primary completion1 Mar 2019
  4. Study completion1 Mar 2019

Resources

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)
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

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.

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