PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar (Other)

Overall Status

Completed

CT.gov ID

NCT03134729

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Lung Neoplasm	Drug: Ropivacaine for Serratus Plane Block (SPB)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 4, 2017

Actual Primary Completion Date :

May 27, 2019

Actual Study Completion Date :

Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serratus Plane Loco-regional 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 plus Ropivacaine (30 ml, 0.3%), for Serratus Plane Block	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.
No Intervention: Standard of Care 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

Arm

Intervention/Treatment

Experimental: Serratus Plane Loco-regional 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 plus Ropivacaine (30 ml, 0.3%), for Serratus Plane Block

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.

No Intervention: Standard of Care

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

Outcome Measures

Primary Outcome Measures

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

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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SacroCuoreDonCalabria Research Hospital	Negrar	Verona	Italy	37024

Sponsors and Collaborators

IRCCS Sacro Cuore Don Calabria di Negrar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

IRCCS Sacro Cuore Don Calabria di Negrar

ClinicalTrials.gov Identifier:

NCT03134729

Other Study ID Numbers:

CHT01

First Posted:

May 1, 2017

Last Update Posted:

Jun 11, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRCCS Sacro Cuore Don Calabria di Negrar

Serratus Block, Pain Management, lung lobectomy

Additional relevant MeSH terms:

Lung Neoplasms

Pain, Postoperative

Ropivacaine

Study Results

No Results Posted as of Jun 11, 2019