Postoperative PainNCT01616550
Quality of Postoperative Pain Management Following Thoracic Surgery
An observational study of Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Assessment of pain using the Brief Pain Questionnaire, Assessment of pain relief using a Verbal Numeric Scale (VNS) and Assessment of patient' satisfaction with pain relief
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective thoracotomy or thoracoscopy in a teaching hospital over a one year period will be considered for this study
Who may be able to join
- Consenting patients aged 18-80 years
- ASA physical status 1-3
- Patients undergoing elective thoracic surgery (thoracotomy/thoracoscopy)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Assessment of pain using the Brief Pain Questionnaire, Assessment of pain relief using a Verbal Numeric Scale (VNS), Assessment of patient' satisfaction with pain relief, Nurse's satisfaction with patient's pain relief and recovery
- Keywords
- analgesia, thoracic surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of pain using the Brief Pain QuestionnaireOther
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 reliefOther
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 recoveryOther
Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing thoracic surgery | Assessment of postoperative pain management in patients undergoing elective thoracoscopy or thoracotomy in a teaching hospital Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief according to analgesic technique
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Secondary outcomes (9)
Consumption of analgesics
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Interference of pain on daily activities
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Patient's satisfaction with pain relief
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Nurse's satisfaction with patient's pain relief, mobility and collaboration
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Length of stay in the recovery room
Measured: From arrival (Day 0) until discharge from the recovery room (Day 0)
Length of stay in the step-down unit
Measured: From arrival (Day 0) until discharge from the step-down unit (Day 1)
Length of stay in the hospital
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Side-effects attributable to analgesia
Measured: From surgery (Day 0) to discharge from the hospital (Day 5)
Presence of postoperative complications
Measured: From surgery (Day 0) until discharge from the hospital (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Boudreault, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616550
- Sponsor's protocol ID
- DB 2012-001
- Status last verified
- Sep 2013
- First submitted
- 7 Jun 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postoperative Pain Management Following Thoracic Surgery: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT01616550
- Acronym / sponsor ID
- DB 2012-001
- Conditions
- Postoperative Pain
- Keywords
- analgesia, thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing thoracic surgery | – | 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 recoveryAssessment of postoperative pain management in patients undergoing elective thoracoscopy or thoracotomy in a teaching hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective thoracotomy or thoracoscopy in a teaching hospital over a one year period will be considered for this study
Key inclusion criteria (3 listed)
- Consenting patients aged 18-80 years
- ASA physical status 1-3
- Patients undergoing elective thoracic surgery (thoracotomy/thoracoscopy)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of pain using the Brief Pain QuestionnairePatients will complete this questionnaire daily from surgery until discharge from the hospital | Other | Patients undergoing thoracic surgery |
| 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 | Patients undergoing thoracic surgery |
| Assessment of patient' satisfaction with pain reliefWill be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied) | Other | Patients undergoing thoracic surgery |
| Nurse's satisfaction with patient's pain relief and recoveryWill be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied) | Other | Patients undergoing thoracic surgery |
Primary outcome
Pain relief according to analgesic technique
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
9 secondary outcomes
Consumption of analgesics
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Interference of pain on daily activities
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Patient's satisfaction with pain relief
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Nurse's satisfaction with patient's pain relief, mobility and collaboration
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Length of stay in the recovery room
Time frame: From arrival (Day 0) until discharge from the recovery room (Day 0)
Length of stay in the step-down unit
Time frame: From arrival (Day 0) until discharge from the step-down unit (Day 1)
Length of stay in the hospital
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Side-effects attributable to analgesia
Time frame: From surgery (Day 0) to discharge from the hospital (Day 5)
Presence of postoperative complications
Time frame: From surgery (Day 0) until discharge from the hospital (Day 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Boudreault, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief according to analgesic technique (time frame: From surgery (Day 0) until discharge from the hospital (Day 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013; AzTrials last refreshed its copy on 8 Nov 2026.