Back to resultsIMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS (POVA)
Primary Purpose
Post-thoracotomy Pain Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
positioning
Sponsored by
About this trial
This is an interventional prevention trial for Post-thoracotomy Pain Syndrome focused on measuring VATS, shoulder pain, pulmonary resection
Eligibility Criteria
Inclusion Criteria:
- Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.
Exclusion Criteria:
surgery extended to the chest wall, including extra-pleural resections,
- Pleurectomy,
- Chronic pain patient suffering from chronic pain preoperatively,
- Fibromyalgia patient,
- Chronic taking of analgesic or anti-inflammatory medications during the preoperative period, namely taking at least daily for more than 4 weeks,
- Patient with a history of orthopedic surgery of the upper limb ipsilateral to the surgery,
- Patient with mechanical limitation of the joint range of the upper limb ipsilateral to surgery,
- Non-French speaking patient,
- Pregnant woman,
- Patient under 18-year-old,
- Patient whose BMI is greater than or equal to 35 kg / m2
- Glomerular filtration rate less than <50 ml / min
Sites / Locations
- Institut Universitaire de Cardiologie et de pneumologie de QuébecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
suspension group
supported group
Arm Description
Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.
Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head.
Outcomes
Primary Outcome Measures
post thoracoscopy shoulder pain measured on the Visual Pain Scale
postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT04415242
First Posted
May 27, 2020
Last Updated
July 13, 2020
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
1. Study Identification
Unique Protocol Identification Number
NCT04415242
Brief Title
IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS
Acronym
POVA
Official Title
IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in the "support" group compared to the "suspension" group.
Detailed Description
The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an extension associated with an abduction of the shoulder on the side operated by suspension of the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of the shoulder in the saggital and frontal planes.
The investigators wish to prospectively and randomly compare this position currently used in the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive for all the joints of the shoulder joint complex in which the patient's arm rests on a support placed in front of the patient's face. It follows from this position of the joint degrees less than or equal to 90 ° in all planes. This new position is not experimental, but not normally used in thoracic surgery at the IUCPQ.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-thoracotomy Pain Syndrome
Keywords
VATS, shoulder pain, pulmonary resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
suspension group
Arm Type
Active Comparator
Arm Description
Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.
Arm Title
supported group
Arm Type
Experimental
Arm Description
Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head.
Intervention Type
Other
Intervention Name(s)
positioning
Intervention Description
different positioning prior surgery
Primary Outcome Measure Information:
Title
post thoracoscopy shoulder pain measured on the Visual Pain Scale
Description
postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed
Time Frame
from the recovery unit to post-operative day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.
Exclusion Criteria:
surgery extended to the chest wall, including extra-pleural resections,
Pleurectomy,
Chronic pain patient suffering from chronic pain preoperatively,
Fibromyalgia patient,
Chronic taking of analgesic or anti-inflammatory medications during the preoperative period, namely taking at least daily for more than 4 weeks,
Patient with a history of orthopedic surgery of the upper limb ipsilateral to the surgery,
Patient with mechanical limitation of the joint range of the upper limb ipsilateral to surgery,
Non-French speaking patient,
Pregnant woman,
Patient under 18-year-old,
Patient whose BMI is greater than or equal to 35 kg / m2
Glomerular filtration rate less than <50 ml / min
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geraud Galvaing, MD, MSc
Phone
+14186564945
Email
geraud.galvaing@clermont.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Sophie Laliberté, MD
Phone
+14186564945
Facility Information:
Facility Name
Institut Universitaire de Cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1v4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geraud Galvaing, MD, MSc
Phone
+14156564945
Email
geraud.galvaing@clermont.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Anne Sophie Laliberté, MD
Phone
+14186564945
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19672167
Citation
Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
Results Reference
background
PubMed Identifier
15365928
Citation
Barak M, Ziser A, Katz Y. Thoracic epidural local anesthetics are ineffective in alleviating post-thoracotomy ipsilateral shoulder pain. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):458-60. doi: 10.1053/j.jvca.2004.05.025.
Results Reference
background
Learn more about this trial
IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS
We'll reach out to this number within 24 hrs