NCT04415242

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

May 27, 2020

Last Update Submit

July 13, 2020

Conditions

Post-thoracotomy Pain Syndrome

Keywords

VATSshoulder painpulmonary resection

Outcome Measures

Primary Outcomes (1)

  • 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

    from the recovery unit to post-operative day 2

Study Arms (2)

suspension group

ACTIVE COMPARATOR

Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.

Other: positioning

supported group

EXPERIMENTAL

Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head.

Other: positioning

Interventions

positioningOTHER

different positioning prior surgery

supported groupsuspension group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de pneumologie de Québec

Québec, Quebec, G1v4G5, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19672167BACKGROUND

  • 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.

    PMID: 15365928BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Geraud Galvaing, MD, MSc

CONTACT

+14186564945geraud.galvaing@clermont.unicancer.fr

Anne Sophie Laliberté, MD

CONTACT

+14186564945

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 4, 2020

Study Start

June 18, 2020

Primary Completion

December 31, 2020

Study Completion

March 30, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)