NCT01616550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

June 7, 2012

Last Update Submit

September 12, 2013

Conditions

Keywords

analgesiathoracic surgery

Outcome Measures

Primary Outcomes (1)

  • Pain relief according to analgesic technique

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

Secondary Outcomes (9)

  • Consumption of analgesics

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

  • Interference of pain on daily activities

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

  • Patient's satisfaction with pain relief

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

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

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

  • Length of stay in the recovery room

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

  • +4 more secondary outcomes

Study Arms (1)

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 QuestionnaireOther: Assessment of pain relief using a Verbal Numeric Scale (VNS)Other: Assessment of patient' satisfaction with pain reliefOther: Nurse's satisfaction with patient's pain relief and recovery

Interventions

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

Patients undergoing thoracic surgery

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

Patients undergoing thoracic surgery

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

Patients undergoing thoracic surgery

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

Patients undergoing thoracic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective thoracotomy or thoracoscopy in a teaching hospital over a one year period will be considered for this study

You may qualify if:

  • Consenting patients aged 18-80 years
  • ASA physical status 1-3
  • Patients undergoing elective thoracic surgery (thoracotomy/thoracoscopy)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

AnalgesiaSalvage Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaTherapeutics

Study Officials

  • Daniel Boudreault, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 16, 2013

Record last verified: 2013-09

Locations