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

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.

Study Overview

• Status: Unknown
• Conditions: Post-thoracotomy Pain Syndrome
• Intervention / Treatment: Other: positioning

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.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • Institut Universitaire de cardiologie et de pneumologie de Quebec
      • Contact: Anne Sophie Laliberté, MD; Phone Number: +14186564945
      • Contact: Geraud Galvaing, MD, MSc; Phone Number: +14156564945; Email: geraud.galvaing@clermont.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: suspension group; Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.	Other: positioning; different positioning prior surgery
EXPERIMENTAL: 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.	Other: positioning; different positioning prior surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): March 30, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: VATS; shoulder pain; pulmonary resection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2020-3430, 21919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No