PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative; Lung Neoplasm
• Interventions: Drug: Ropivacaine for Serratus Plane Block (SPB)

• Registration Number: NCT03134729
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Study Start: 2017-05-04
• Primary Completion: 2019-05-27
• Status Verified: 2019-06
• Study Completion: 2019-06-04
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus Plane Loco-regional block	Ropivacaine for Serratus Plane Block (SPB)	* 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

Primary Outcome Measures

Name	Time	Method
Post operative pain perception	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 Outcome Measures

Name	Time	Method
Systemic rescue analgesia consumption (doses)	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)
Ability to perform post operative rehab exercises	Measured at 24 hrs and 48 hrs after surgery	Number of forced inspiratory maneuvers during rehab respiratory exercises

Trial Locations

Locations (1)

SacroCuoreDonCalabria Research Hospital; 🇮🇹 Negrar, Verona, Italy