PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2019-06-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative Lung Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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

Group Type EXPERIMENTAL

Ropivacaine for Serratus Plane Block (SPB)

Intervention Type DRUG

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No