Quality of Postoperative Pain Management Following Thoracic Surgery
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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. |
- Pain relief according to analgesic technique [ Time Frame: From surgery (Day 0) until discharge from the hospital (Day 5) ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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 |
Patients undergoing elective thoracotomy or thoracoscopy in a teaching hospital over a one year period will be considered for this study
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| Contact: Daniel Boudreault, MD, FRCPC | 514-890-8000 ext 26876 | drboudreault@videotron.ca |
| Contact: Alain Gauthier, MD, FRCPC | 514-890-8000 ext 26876 | alain.gauthier.1@umontreal.ca |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal | Recruiting |
| Montréal, Quebec, Canada, H2L 4M1 | |
| Contact: Daniel Boudreault, MD, FRCPC 514-890-8000 ext 26876 drboudreault@videotron.ca | |
| Contact: Monique Ruel, RN, CCRP 514-890-8000 ext 24542 monique.m.ruel.chum@ssss.gouv.qc.ca | |
| Sub-Investigator: Sébastien Garneau, MD, FRCPC | |
| 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: | March 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 May 22, 2013