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NCT Number: NCT03134729

PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.

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Key information

Conditions

Pain, Postoperative Agnosia Lung Diseases Lung Neoplasm Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SacroCuoreDonCalabria Research Hospital

Negrar, Verona, 37024, Italy

About this study

A prospective randomized trial comparing intravenous analgesia alone and in association with loco regional anesthesia consisting in a homolateral Serratus Plan Block (SPB). Loco regional blockade of the serratus is further examined by allocating the patients to two different approaches: the block being performed under US guidance by the Anesthesiologist before the beginning of the procedure, or under direct visualization, by the operating surgeon, before entering the pleural cavity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Lobectomy/ Segmentectomy plus lymphadenectomy (systematic or sampling) for cancer (not necessarily NSCLC) performed with a standardized, three portal minimally invasive approach.

Exclusion criteria

  • Patients who are pregnant or lactating
  • Morbid obesity (BMI > 35 )
  • Inability to understand and sign the Informed consent
  • Proven allergy to local anesthetic drugs as required by this protocol
  • Patients under chronic analgesics or neuroleptic therapy for any reason and/ or with baseline pain score (NRS scale) of 3 or more.

Treatment and study plan

Ropivacaine for Serratus Plane Block (SPB)

Drug

Serratus Plane Block (SPB) injection of low concentration Ropivacaine (30 ml, 0.3%), in the plane between the External Intercostal Muscle and the Serratus Anterior Muscle.

Primary outcomes

  1. Post operative pain perception

    Time frame: 24 hours from the end of surgery

    Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10).

Secondary outcomes

  1. Ability to perform post operative rehab exercises

    Time frame: Measured at 24 hrs and 48 hrs after surgery

    Number of forced inspiratory maneuvers during rehab respiratory exercises

  2. Systemic rescue analgesia consumption (doses)

    Time frame: measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery

    Number of extra doses of pain killers directly required by the patient (Morphine (0.1 mg/kg), Tramadol 100 mg or Ketorolac 30 mg)

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

PATHOS Study Pain Assessment in Thoracic Oncologic Surgery: a Prospective Randomized Trial on Pain Management After Video Assisted Major Lung Resections.

Acronym: PATHOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 1, 2017
Registry last updated
Jun 11, 2019

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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