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PATHOS Study Pain Assessment in Thoracic Oncologic Surgery (PATHOS)

Primary Purpose

Pain, Postoperative, Lung Neoplasm

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Ropivacaine for Serratus Plane Block (SPB)

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Serratus Block, Pain Management, lung lobectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

SacroCuoreDonCalabria Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Serratus Plane Loco-regional block

Standard of Care

Arm 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

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

Outcomes

Primary Outcome Measures

Post operative pain perception

Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10).

Secondary Outcome Measures

Ability to perform post operative rehab exercises

Number of forced inspiratory maneuvers during rehab respiratory exercises

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)

Full Information

NCT ID

NCT03134729

First Posted

April 2, 2017

Last Updated

June 7, 2019

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

1. Study Identification

Unique Protocol Identification Number

NCT03134729

Brief Title

PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

Acronym

PATHOS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

May 4, 2017 (Actual)

Primary Completion Date

May 27, 2019 (Actual)

Study Completion Date

June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Lung Neoplasm

Keywords

Serratus Block, Pain Management, lung lobectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

Given the trial Design, it would be impossible to blind the caregiver about the type of treatment. Serratus Plan Block will be performed after the induction of General Anesthesia, the patients will thus be unaware wether being assigned to the Experimental or Control Arm. Clarification (May 28, 2018): Nurses assess NRS (Pain Perception) and directly manage rescue doses delivery Physiotherapists deliver rehab. respiratory exercises and directly assess patient's performance. Since their reports are directly elicited in Clinical Report Forms, they are considered outcome assessors. Both Nurses and Physiotherapists are unaware of treatment allocation.

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Serratus Plane Loco-regional block

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ropivacaine for Serratus Plane Block (SPB)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post operative pain perception

Description

Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10).

Time Frame

24 hours from the end of surgery

Secondary Outcome Measure Information:

Title

Ability to perform post operative rehab exercises

Description

Number of forced inspiratory maneuvers during rehab respiratory exercises

Time Frame

Measured at 24 hrs and 48 hrs after surgery

Title

Systemic rescue analgesia consumption (doses)

Description

Number of extra doses of pain killers directly required by the patient (Morphine (0.1 mg/kg), Tramadol 100 mg or Ketorolac 30 mg)

Time Frame

measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

SacroCuoreDonCalabria Research Hospital

City

Negrar

State/Province

Verona

ZIP/Postal Code

37024

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23923989

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.

Results Reference

background

PubMed Identifier

25913824

Citation

Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen 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 cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26.

Results Reference

result

PubMed Identifier

27160473

Citation

Bendixen M, Jorgensen 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 Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.

Results Reference

result

PubMed Identifier

24288340

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.

Results Reference

result

PubMed Identifier

26449303

Citation

Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available.

Results Reference

result

PubMed Identifier

31808538

Citation

Viti A, Bertoglio P, Zamperini M, Tubaro A, Menestrina N, Bonadiman S, Avesani R, Guerriero M, Terzi A. Serratus plane block for video-assisted thoracoscopic surgery major lung resection: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2020 Mar 1;30(3):366-372. doi: 10.1093/icvts/ivz289.

Results Reference

derived

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PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

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