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Completed

NCT Number: NCT02173418

The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy

The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.

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Key information

Conditions

Postoperative Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Departement of Anaesthesia and intensive care, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients planned for elective lobectomy or pneumonectomy
  • 18 years or more on the day of the operation
  • Danish skills appropriate for fulfilling preoperative questionnaires

Exclusion criteria

  • Known contralateral paresis of the Phrenic nerve
  • Allergy to Ropivacaine or Sodium Chloride
  • Preoperative ipsilateral shoulder pain
  • Infection or eczema on the intervention site. Clinical decision
  • Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
  • Pregnancy
  • Acute porphyria

Treatment and study plan

Phrenic nerve block with Ropivacaine

Drug

Other names: Naropin

Phrenic nerve block with saline

Drug

Other names: Sodium Chloride

Primary outcomes

  1. Shoulder pain within 6 hours after the operation

    Time frame: Retrospective numerical rating scale, 6 hours after the operation

    Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)

Secondary outcomes

  1. Number of patients with shoulder pain during the first 3 postoperative days.

    Time frame: Postoperative days 0-3

  2. NRS for shoulder pain during the first 3 postoperative days.

    Time frame: Postoperative days 0-3

    NRS=numerical rating scale score 0-10

  3. Opioid use during the first 3 postoperative days

    Time frame: Postoperative day 0-3

    Morphine equivalents

  4. Time spent in the recovery room

    Time frame: Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.

  5. Shoulder pain 3 months postoperatively

    Time frame: 3 months postoperatively

  6. NRS for shoulder pain 3 months postoperatively

    Time frame: 3 months postoperatively

    NRS=numerical rating scale 0-10

  7. Thoracic pain 3 months postoperatively

    Time frame: 3 months postoperatively

  8. NRS for thoracic pain 3 months postoperatively

    Time frame: 3 months postoperatively

    NRS=numerical rating scale 0-10

  9. opioid use 3 months postoperatively

    Time frame: 3 months postoperatively

  10. Shoulder function 3 months postoperatively

    Time frame: 3 months postoperatively

    Measured by DASH-score before the operation and after 3 months

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Læge Fritz Karners og hustrus Foundation
  • Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study title

The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.

Acronym: TOPBLOC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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