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

NCT03439566 | Completed DMC

• 1 other identifier: SM4-AG-17
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

pain measures; prediction of pain; pain management

Outcome Measures

Primary Outcomes (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

  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

  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

  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.

  24 hour postoperatively

• A patient diary, investigating postoperative pain levels, sleep and mood

  Day 1 to 5 postoperatively

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing total hip arthroplasty (THA) at Zealand University Hospital, Koege meeting the inclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Koege

Copenhagen, Køge, 4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32126971 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Anja Geisler, PhD student

  Zealand University Hospital, Koege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student/ clinical nurse specialist

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: February 20, 2018
• Study Start: January 15, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

DK (1)