PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

Pain, Postoperative Clinical Trial

— PATHOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134729
• Other study ID #: CHT01
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: June 4, 2019

Study information

• Verified date: June 2019
• Source: Sacro Cuore Don Calabria General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 4, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Italy	SacroCuoreDonCalabria Research Hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Sacro Cuore Don Calabria General Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bendixen M, Jørgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Onc — View Citation

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation

Broseta AM, Errando C, De Andrés J, Díaz-Cambronero O, Ortega-Monzó J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. — View Citation

Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hürtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung can — View Citation

Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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