Clinical trial NCT01616550: Quality of Postoperative Pain Management Following Thoracic Surgery
Official title: Quality of Postoperative Pain Management Following Thoracic Surgery: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: analgesia
thoracic surgery
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Pain relief according to analgesic technique
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
Secondary outcomes:
measure: Consumption of analgesics
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
measure: Interference of pain on daily activities
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
measure: Patient's satisfaction with pain relief
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
measure: Nurse's satisfaction with patient's pain relief, mobility and collaboration
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
measure: Length of stay in the recovery room
timeFrame: From arrival (Day 0) until discharge from the recovery room (Day 0)
measure: Length of stay in the step-down unit
timeFrame: From arrival (Day 0) until discharge from the step-down unit (Day 1)
measure: Length of stay in the hospital
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
measure: Side-effects attributable to analgesia
timeFrame: From surgery (Day 0) to discharge from the hospital (Day 5)
measure: Presence of postoperative complications
timeFrame: From surgery (Day 0) until discharge from the hospital (Day 5)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel Boudreault, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: