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Pain Control After VATS Anatomical Pulmonary Resections

Primary Purpose

Lung Cancer, Pain, Postoperative, Thoracic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Epidural
ESP block
Cryoanalgesia
Sponsored by
University Hospital Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring thoracoscopic surgery, post-operative pain, epidural anesthesia, ESP block, cryoanalgesia, lobectomy

Eligibility Criteria

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

Inclusion Criteria: all patients undergoing VATS anatomic pulmonary resection (lobectomy or segmentectomy) for benign or malignant disease Exclusion Criteria: Refusal or inability to give informed consent to the study protocol Age < 18 years Pregnancy Allergies or contraindications to any of the treatments considered in the experimental design Pre-operative use of pain medication for chronic pain or neuropathic pain History of previous major chest surgery American Society of Anesthesiologists (ASA) class > 3 Need for intensive care unit stay in the post-operative period Patients undergoing anatomical pulmonary resections different than lobectomy or segmentectomy (bi-lobectomy or pneumonectomy). Patients undergoing bronchial and/or vascular resections and reconstructions

Sites / Locations

  • Thoracic Surgery UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Epidural

ESP block

Cryoanalgesia

Arm Description

In patients randomized to this Arm, before the induction of general anesthesia, the epidural catheter is placed in the intervertebral space (T4-T5, T5-6 or T6-T7) and used intra and post-operatively for administration of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia the Erector spinae plane (ESP) block is performed with a catheter introduced and left in place for continuous postoperative infusion of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia and single lung ventilation the first thoracoscopic surgical access is performed. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access and the active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8.

Outcomes

Primary Outcome Measures

Post-operative pain
Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

Secondary Outcome Measures

Post-operative pain trend
Perceived post-operative pain 1,6,12 and 48 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)
Rescue Analgesia
patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents)

Full Information

First Posted
July 25, 2023
Last Updated
August 11, 2023
Sponsor
University Hospital Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05993273
Brief Title
Pain Control After VATS Anatomical Pulmonary Resections
Official Title
Pain Control After VATS Anatomical Pulmonary Resections: Randomized Comparison Between Cryoanalgesia, Erector Spinae Plane Block and Epidural Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain. In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications. Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences. The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.
Detailed Description
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain. In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications. Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences. The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery. All patients undergoing anatomical pulmonary resections (lobectomy or segmentectomy) through a thoracoscopic (VATS) approach, and who present the inclusion/exclusion characteristics, will be considered. The day of surgery, patients are randomized 1:1:1 to receive 3 different pain control techniques: epidural catheter, ESP block or cryoanalgesia. A standard pain management protocol will be applied to all patient after surgery. Primary Outcome Measure is the perceived post-operative pain 24 hours after surgery in the 3 groups, evaluated through numeric pain rating scale (NPRS). Other outcome measures are the post-operative pain trend and the patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Pain, Postoperative, Thoracic Neoplasms
Keywords
thoracoscopic surgery, post-operative pain, epidural anesthesia, ESP block, cryoanalgesia, lobectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural
Arm Type
Experimental
Arm Description
In patients randomized to this Arm, before the induction of general anesthesia, the epidural catheter is placed in the intervertebral space (T4-T5, T5-6 or T6-T7) and used intra and post-operatively for administration of local anesthetics.
Arm Title
ESP block
Arm Type
Experimental
Arm Description
In patients randomized to this Arm, after induction of general anesthesia the Erector spinae plane (ESP) block is performed with a catheter introduced and left in place for continuous postoperative infusion of local anesthetics.
Arm Title
Cryoanalgesia
Arm Type
Experimental
Arm Description
In patients randomized to this Arm, after induction of general anesthesia and single lung ventilation the first thoracoscopic surgical access is performed. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access and the active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8.
Intervention Type
Procedure
Intervention Name(s)
Epidural
Intervention Description
The epidural catheter is placed while the patient is awake, before the induction of general anesthesia. The intervertebral spaces used for catheter insertion are alternatively T4-T5, T5-6 or T6-T7. After locating the epidural space through the technique of the loss of resistance, a catheter is introduced for about 5 cm and left in place for the administration of drugs into the epidural space. Once the correct functioning of the epidural catheter has been verified with a negative test for cerebrospinal fluid aspiration and a negative bolus test for the onset of signs and symptoms from intrathecal infusion, the catheter is used intraoperatively for administration of local anesthetics in refracted boluses (Lidocaine and Ropivacaine ) at anesthetic dosage and postoperatively for continuous infusion of Ropivacaine 0.15% at 5 mL/h.
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
Erector spinae plane (ESP) block is performed after induction of general anesthesia, with the patient in a lateral decubitus position. With the aid of the ultrasound guide with linear probe, the transverse process of T5 ipsilateral to the site of the operation is identified. With the in-plane technique, the lower fascia of the ESP muscle is hydrodissected through the administration of Ropivacaine 0.5% 3 mg/Kg lean body weight. Subsequently, a catheter is introduced and left in place for continuous postoperative infusion of Ropivacaine 0.2% at 12 mL/h.
Intervention Type
Procedure
Intervention Name(s)
Cryoanalgesia
Intervention Description
Cryoanalgesia is performed after the induction of general anesthesia, single lung ventilation and after performing the first thoracoscopic surgical access. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access. The active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8 and kept resting for 4 ½ minutes on each nerve at a temperature of -70°C, under direct thoracoscopic vision, generating an interruption of the sensory functions.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Post-operative pain trend
Description
Perceived post-operative pain 1,6,12 and 48 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)
Time Frame
1,6,12 and 48 hours after surgery
Title
Rescue Analgesia
Description
patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents)
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients undergoing VATS anatomic pulmonary resection (lobectomy or segmentectomy) for benign or malignant disease Exclusion Criteria: Refusal or inability to give informed consent to the study protocol Age < 18 years Pregnancy Allergies or contraindications to any of the treatments considered in the experimental design Pre-operative use of pain medication for chronic pain or neuropathic pain History of previous major chest surgery American Society of Anesthesiologists (ASA) class > 3 Need for intensive care unit stay in the post-operative period Patients undergoing anatomical pulmonary resections different than lobectomy or segmentectomy (bi-lobectomy or pneumonectomy). Patients undergoing bronchial and/or vascular resections and reconstructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARCO MAMMANA, MD, PhD
Phone
+390498212442
Email
marco.mammana@aopd.veneto.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCO MAMMANA, MD, PhD
Organizational Affiliation
PADUA UNIVERSITY HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoracic Surgery Unit
City
Padua
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARCO MAMMANA, MD,PhD
Phone
+390498212442
Email
marco.mammana@aopd.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29980005
Citation
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Results Reference
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Results Reference
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28188621
Citation
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Results Reference
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Citation
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Pain Control After VATS Anatomical Pulmonary Resections

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