Pain Control After VATS Anatomical Pulmonary Resections

Not Applicable

Recruiting

• Conditions: Lung Cancer; Pain, Postoperative; Thoracic Neoplasms
• Interventions: Procedure: ESP block; Procedure: Epidural; Procedure: Cryoanalgesia

• Registration Number: NCT05993273
• Lead Sponsor: University Hospital Padova

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).

Study Timeline

• Study Start: 2023-04-05
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• all patients undergoing VATS anatomic pulmonary resection (lobectomy or segmentectomy) for benign or malignant disease

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block	ESP block	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.
Epidural	Epidural	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.
Cryoanalgesia	Cryoanalgesia	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	24 hours after surgery	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

Name	Time	Method
Post-operative pain trend	1,6,12 and 48 hours after surgery	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	48 hours after surgery	patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents)

Trial Locations

Locations (1)

Thoracic Surgery Unit; 🇮🇹 Padua, Italy