Quality of Postoperative Pain Management Following Thoracic Surgery

Quality of Postoperative Pain Management Following Thoracic Surgery: a Prospective Observational Study.

The purpose of this study is to assess the quality of postoperative pain management in a Canadian teaching hospital following thoracic surgery.

Hypothesis: Postoperative pain management following thoracotomy or thoracoscopy is still suboptimal despite the evidence that adequate pain relief improves outcome.

Study Overview

Detailed Description

Pain is an expected outcome of surgery. However, many patients experience suboptimally managed postoperative pain. Benefits of adequate analgesia no longer need to be demonstrated. Optimal analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances patient's satisfaction and quality of life following surgery.

Currently, approximately 1000 thoracic surgeries are performed in our hospital annually. Many of these surgeries that previously required a thoracotomy incision are now performed under Video-Assisted Thoracoscopy Surgery (VATS). Although VATS is known to be less invasive and causes less pain than thoracotomy, some patients still experience considerable pain following thoracoscopy especially during the first hours following surgery.

Thoracic epidural has emerged as the preferred pain control technique following thoracotomy. However, the role of epidural analgesia after thoracoscopy remains debatable. The ideal postoperative analgesia regimen for the short-duration but intense pain related to thoracoscopy has not been elucidated. Paravertebral blockade is an alternative to epidural analgesia. However, the duration of pain relief associated with this technique may vary from 4 to 48 hours. Systemic opioids given through patient-controlled devices may be used after thoracic surgery but the analgesic effect can be limited and undesirable side-effects may occur.

This prospective observational study will investigate the quality of pain management following thoracic surgery and assess patient's and nurse's satisfaction regarding pain relief in a teaching hospital.

Methods:

Patients scheduled for elective thoracic surgery to be performed by thoracotomy or thoracoscopy will be considered for this prospective observational study.

The surgical approach and pain management plan will not be modified by the patient's participation to the study. According to standard practice in our hospital, pain will be assessed using a Verbal Numeric Scale from 0 to 10.

Type of analgesic technique, consumption of opioid and non-opioid drugs, type and duration of surgery will be noted. Side-effects attributable to analgesia and associated treatment will be recorded. Length of stay in the recovery room, step-down unit and in the hospital will also be recorded. Postoperative complications will be assessed.

Patients will be invited to complete the short form of the "Brief Pain Inventory". They will be asked to grade their satisfaction with pain relief using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied). Nurses will be asked to provide their opinion on patient's pain relief, ability to move and collaboration.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective thoracotomy or thoracoscopy in a teaching hospital over a one year period will be considered for this study

Description

Inclusion Criteria:

  • Consenting patients aged 18-80 years
  • ASA physical status 1-3
  • Patients undergoing elective thoracic surgery (thoracotomy/thoracoscopy)

Exclusion Criteria:

  • Current regular use of drugs belonging to the class of opioids
  • Presence of a coexisting chronic pain syndrome
  • The inability to understand a verbal numeric pain scale (VNS) despite previous instruction
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing thoracic surgery
Assessment of postoperative pain management in patients undergoing elective thoracoscopy or thoracotomy in a teaching hospital
Patients will complete this questionnaire daily from surgery until discharge from the hospital
Patients will assess their pain daily from surgery until discharge from the hospital using the VNS
Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)
Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain relief according to analgesic technique
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)

Secondary Outcome Measures

Outcome Measure
Time Frame
Consumption of analgesics
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)
Interference of pain on daily activities
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)
Patient's satisfaction with pain relief
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)
Nurse's satisfaction with patient's pain relief, mobility and collaboration
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)
Length of stay in the recovery room
Time Frame: From arrival (Day 0) until discharge from the recovery room (Day 0)
From arrival (Day 0) until discharge from the recovery room (Day 0)
Length of stay in the step-down unit
Time Frame: From arrival (Day 0) until discharge from the step-down unit (Day 1)
From arrival (Day 0) until discharge from the step-down unit (Day 1)
Length of stay in the hospital
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)
Side-effects attributable to analgesia
Time Frame: From surgery (Day 0) to discharge from the hospital (Day 5)
From surgery (Day 0) to discharge from the hospital (Day 5)
Presence of postoperative complications
Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5)
From surgery (Day 0) until discharge from the hospital (Day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Boudreault, MD, FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (ESTIMATE)

June 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • DB 2012-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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