Pain Control After VATS Anatomical Pulmonary Resections

Trial Title: Pain Control After VATS Anatomical Pulmonary Resections

NCT ID: NCT05993273

Condition: Lung Cancer
Pain, Postoperative
Thoracic Neoplasms

Conditions: Official terms:
Thoracic Neoplasms
Pain, Postoperative

Conditions: Keywords:
thoracoscopic surgery
post-operative pain
epidural anesthesia
ESP block
cryoanalgesia
lobectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Epidural
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.
Arm group label: Epidural

Intervention type: Procedure
Intervention name: ESP block
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.
Arm group label: ESP block

Intervention type: Procedure
Intervention name: Cryoanalgesia
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.
Arm group label: Cryoanalgesia

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Thoracic Surgery Unit

Address:
City: Padua
Zip: 35128
Country: Italy

Status: Recruiting

Contact:
Last name: MARCO MAMMANA, MD,PhD

Phone: +390498212442
Email: marco.mammana@aopd.veneto.it

Start date: April 5, 2023

Completion date: April 15, 2025

Lead sponsor:
Agency: University Hospital Padova
Agency class: Other

Source: University Hospital Padova

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05993273