Trial | NCT03134729  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ropivacaine ...

  • Study Participants

    90
A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.
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 Started
May 04
2017
Primary Completion
May 27
2019
Study Completion
Jun 04
2019
Last Update
Jun 11
2019

Drug Ropivacaine for Serratus Plane Block (SPB)

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.

Serratus Plane Loco-regional block Experimental

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

Standard of Care No Intervention

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

Criteria 

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.
No Results Posted