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Completed

NCT Number: NCT01616550

Quality of Postoperative Pain Management Following Thoracic Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of pain using the Brief Pain Questionnaire

Other

Patients will complete this questionnaire daily from surgery until discharge from the hospital

Assessment of pain relief using a Verbal Numeric Scale (VNS)

Other

Patients will assess their pain daily from surgery until discharge from the hospital using the VNS

Assessment of patient' satisfaction with pain relief

Other

Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)

Nurse's satisfaction with patient's pain relief and recovery

Other

Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)

Primary outcomes

  1. Pain relief according to analgesic technique

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

Secondary outcomes

  1. Consumption of analgesics

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

  2. Interference of pain on daily activities

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

  3. Patient's satisfaction with pain relief

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

  4. Nurse's satisfaction with patient's pain relief, mobility and collaboration

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

  5. Length of stay in the recovery room

    Time frame: From arrival (Day 0) until discharge from the recovery room (Day 0)

  6. Length of stay in the step-down unit

    Time frame: From arrival (Day 0) until discharge from the step-down unit (Day 1)

  7. Length of stay in the hospital

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

  8. Side-effects attributable to analgesia

    Time frame: From surgery (Day 0) to discharge from the hospital (Day 5)

  9. Presence of postoperative complications

    Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2012
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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