PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Completed

Conditions: Pain, Postoperative; Lung Neoplasm

Treatments: Drug: Ropivacaine for Serratus Plane Block (SPB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03134729

CHT01

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Serratus Plane Loco-regional block

Experimental group

Description:

* 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

Treatment:

Drug: Ropivacaine for Serratus Plane Block (SPB)

Standard of Care

No Intervention group

Description:

* 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