PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

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

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Lung Neoplasm

Intervention / Treatment
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* Drug: Ropivacaine for Serratus Plane Block (SPB)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized between two groups: Systemic analgesic therapy only (Endovenous/ Oral) Systemic analgesic therapy plus loco regional therapy administered under Us. guidance before the procedure (Serratus Plane Block). Allocation to one treatment group or another will be randomized with the aim of create two unbiased groups formed out of the same group of patients. Randomization will be provided by a software. Group allocation and treatment is overt to the investigators, but not to the patient.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus Plane Loco-regional block<br>Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours plus Ropivacaine (30 ml, 0.3%), for Serratus Plane Block | Drug: Ropivacaine for Serratus Plane Block (SPB)<br>* 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.<br>|
| No Intervention: Standard of Care<br>Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain perception | Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10). | 24 hours from the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to perform post operative rehab exercises | Number of forced inspiratory maneuvers during rehab respiratory exercises | Measured at 24 hrs and 48 hrs after surgery | 
| Systemic rescue analgesia consumption (doses) | Number of extra doses of pain killers directly required by the patient (Morphine (0.1 mg/kg), Tramadol 100 mg or Ketorolac 30 mg) | measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus Block, Pain Management, lung lobectomy