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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04415242
Other study ID # 2020-3430, 21919
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 18, 2020
Est. completion date March 30, 2021

Study information

Verified date July 2020
Source Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Contact Geraud Galvaing, MD, MSc
Phone +14186564945
Email geraud.galvaing@clermont.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 134
Est. completion date March 30, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
positioning
different positioning prior surgery

Locations

Country Name City State
Canada Institut Universitaire de Cardiologie et de pneumologie de Québec Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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