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Does Preoperative Pain Levels by Venipuncture Predict Late Postoperative Pain Levels?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439566
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Anja Geisler, Zealand University Hospital

Brief 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. 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.

Condition or disease
Pain, Postoperative

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 [ 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 ]
    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?

  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 [ Time Frame: Postoperatively at discharge from the PACU up to 4h postoperatively and 24 hours 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 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.

  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. [ Time Frame: 24 hour postoperatively ]
    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?

  4. A patient diary, investigating postoperative pain levels, sleep and mood [ Time Frame: Day 1 to 5 postoperatively ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing total hip arthroplasty (THA) at Zealand University Hospital, Koege meeting the inclusion criteria
Criteria

Inclusion Criteria:

  • Patients undergoing total hip arthroplasty in spinal anaesthesia
  • Patients who understand and speak Danish or English

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439566


Locations
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Denmark
Zealand University Hospital, Koege
Copenhagen, Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Anja Geisler, PhD student Zealand University Hospital, Koege
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anja Geisler, PhD student/ clinical nurse specialist, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03439566    
Other Study ID Numbers: SM4-AG-17
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anja Geisler, Zealand University Hospital:
pain measures
prediction of pain
pain management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms