CClinicalTrials.gg
Status unknownNCT04415242POVAUpdated Jul 15, 2020

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

An interventional study of positioning in Post-thoracotomy Pain Syndrome, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-thoracotomy Pain Syndrome

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Keywords

  • VATS
  • shoulder pain
  • pulmonary resection
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's planned enrollment of 134 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
134 participants (estimated)

Study arms

  • Active comparator
    suspension group

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

    Other: positioning

  • 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

Interventions

  • Otherpositioning

    different positioning prior surgery

06

What researchers measure

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

    Time frame: from the recovery unit to post-operative day 2

07

Study locations

1 of 1 sites recruiting
  • Institut Universitaire de Cardiologie et de pneumologie de Québec
    Québec, Quebec G1v4G5, Canada
    Recruiting
08

References and documents

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. PubMed 19672167 ↗
  • 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. PubMed 15365928 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04415242
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Responsible party
Geraud Galvaing (MD, MSc, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec) — Principal investigator
First posted
Jun 4, 2020
Start date
Jun 18, 2020
Primary completion
Dec 31, 2020 (estimated)
Completion
Mar 30, 2021 (estimated)
Last update
Jul 15, 2020

Study contacts

Geraud Galvaing, MD, MSc
Contact
geraud.galvaing@clermont.unicancer.fr
+14186564945
Anne Sophie Laliberté, MD
Contact
+14186564945

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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