Quality of Postoperative Pain Management Following Thoracic Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616550
• Other study ID #: DB 2012-001
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: September 12, 2013
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Assessment of pain using the Brief Pain Questionnaire
Patients will complete this questionnaire daily from surgery until discharge from the hospital
• 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
• 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)
• 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)

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief according to analgesic technique		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Consumption of analgesics		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Interference of pain on daily activities		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Patient's satisfaction with pain relief		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Nurse's satisfaction with patient's pain relief, mobility and collaboration		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Length of stay in the recovery room		From arrival (Day 0) until discharge from the recovery room (Day 0)	No
Secondary	Length of stay in the step-down unit		From arrival (Day 0) until discharge from the step-down unit (Day 1)	No
Secondary	Length of stay in the hospital		From surgery (Day 0) until discharge from the hospital (Day 5)	No
Secondary	Side-effects attributable to analgesia		From surgery (Day 0) to discharge from the hospital (Day 5)	No
Secondary	Presence of postoperative complications		From surgery (Day 0) until discharge from the hospital (Day 5)	No