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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

June 7, 2012
September 12, 2013
September 2012
September 2013   (final data collection date for primary outcome measure)
Pain relief according to analgesic technique [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01616550 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Postoperative Pain
  • 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)
Patients undergoing thoracic surgery
Assessment of postoperative pain management in patients undergoing elective thoracoscopy or thoracotomy in a teaching hospital
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01616550
DB 2012-001
No
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Not Provided
Principal Investigator: Daniel Boudreault, MD, FRCPC Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP