IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS

NCT ID: NCT04415242

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2021-03-30

Brief Summary

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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

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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.

Conditions

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Post-thoracotomy Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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suspension group

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

Group Type ACTIVE_COMPARATOR

positioning

Intervention Type OTHER

different positioning prior surgery

supported group

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

Group Type EXPERIMENTAL

positioning

Intervention Type OTHER

different positioning prior surgery

Interventions

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positioning

different positioning prior surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role lead

Responsible Party

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Geraud Galvaing

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institut Universitaire de Cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Geraud Galvaing, MD, MSc

Role: CONTACT

+14186564945

Anne Sophie Laliberté, MD

Role: CONTACT

+14186564945

Facility Contacts

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Geraud Galvaing, MD, MSc

Role: primary

+14156564945

Anne Sophie Laliberté, MD

Role: backup

+14186564945

References

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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.

Reference Type BACKGROUND
PMID: 19672167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15365928 (View on PubMed)

Other Identifiers

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2020-3430, 21919

Identifier Type: -

Identifier Source: org_study_id

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