Quality of Postoperative Pain Management Following Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01616550
First received: June 7, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Postoperative Pain
Other: Assessment of pain using the Brief Pain Questionnaire
Other: Assessment of pain relief using a Verbal Numeric Scale (VNS)
Other: Assessment of patient' satisfaction with pain relief
Other: Nurse's satisfaction with patient's pain relief and recovery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Postoperative Pain Management Following Thoracic Surgery: a Prospective Observational Study.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Pain relief according to analgesic technique [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Consumption of analgesics [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Interference of pain on daily activities [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Patient's satisfaction with pain relief [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Nurse's satisfaction with patient's pain relief, mobility and collaboration [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Length of stay in the recovery room [ Time Frame: From arrival (Day 0) until discharge from the recovery room (Day 0) ] [ Designated as safety issue: No ]
  • Length of stay in the step-down unit [ Time Frame: From arrival (Day 0) until discharge from the step-down unit (Day 1) ] [ Designated as safety issue: No ]
  • Length of stay in the hospital [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Side-effects attributable to analgesia [ Time Frame: From surgery (Day 0) to discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
  • Presence of postoperative complications [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients undergoing thoracic surgery
Assessment of postoperative pain management in patients undergoing elective thoracoscopy or thoracotomy in a teaching hospital
Other: Assessment of pain using the Brief Pain Questionnaire
Patients will complete this questionnaire daily from surgery until discharge from the hospital
Other: Assessment of pain relief using a Verbal Numeric Scale (VNS)
Patients will assess their pain daily from surgery until discharge from the hospital using the VNS
Other: Assessment of patient' satisfaction with pain relief
Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)
Other: Nurse's satisfaction with patient's pain relief and recovery
Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616550

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Daniel Boudreault, MD, FRCPC Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01616550     History of Changes
Other Study ID Numbers: DB 2012-001
Study First Received: June 7, 2012
Last Updated: September 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
analgesia
thoracic surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014