Clinical trial NCT05993273: 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
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Pain, Postoperative
Thoracic Neoplasms
Keywords: thoracoscopic surgery
post-operative pain
epidural anesthesia
ESP block
cryoanalgesia
lobectomy
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Post-operative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Post-operative pain trend
timeFrame: 1,6,12 and 48 hours after surgery
measure: Rescue Analgesia
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Thoracic Surgery Unit
Study officials:
affiliation: PADUA UNIVERSITY HOSPITAL
name: MARCO MAMMANA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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