Pain Control After VATS Anatomical Pulmonary Resections

NCT05993273 | Completed

• 1 other identifier: 5697/AO/23
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Pain, Postoperative; Thoracic Neoplasms

Keywords

thoracoscopic surgery; post-operative pain; epidural anesthesia; ESP block; cryoanalgesia; lobectomy

Outcome Measures

Primary Outcomes (1)

• 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)

  24 hours after surgery

Secondary Outcomes (2)

• Post-operative pain trend

  1,6,12 and 48 hours after surgery

• Rescue Analgesia

  48 hours after surgery

Study Arms (3)

Epidural

EXPERIMENTAL

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.

Procedure: Epidural

ESP block

EXPERIMENTAL

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.

Procedure: ESP block

Cryoanalgesia

EXPERIMENTAL

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.

Procedure: Cryoanalgesia

Interventions

Epidural PROCEDURE

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.

Epidural

ESP block PROCEDURE

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.

ESP block

Cryoanalgesia PROCEDURE

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.

Cryoanalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Thoracic Surgery Unit

Padua, 35128, Italy

Location

Related Publications (10)

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

  PMID: 28188621 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.

  PMID: 23424242 BACKGROUND

• Ju H, Feng Y, Yang BX, Wang J. Comparison of epidural analgesia and intercostal nerve cryoanalgesia for post-thoracotomy pain control. Eur J Pain. 2008 Apr;12(3):378-84. doi: 10.1016/j.ejpain.2007.07.011. Epub 2007 Sep 17.

  PMID: 17870625 BACKGROUND

• Torre M, Mameli L, Bonfiglio R, Guerriero V, Derosas L, Palomba L, Disma N. A New Device for Thoracoscopic Cryoanalgesia in Pectus Excavatum Repair: Preliminary Single Center Experience. Front Pediatr. 2021 Jan 18;8:614097. doi: 10.3389/fped.2020.614097. eCollection 2020.

  PMID: 33585365 BACKGROUND

• Lin J, Liao Y, Gong C, Yu L, Gao F, Yu J, Chen J, Chen X, Zheng T, Zheng X. Regional Analgesia in Video-Assisted Thoracic Surgery: A Bayesian Network Meta-Analysis. Front Med (Lausanne). 2022 Apr 6;9:842332. doi: 10.3389/fmed.2022.842332. eCollection 2022.

  PMID: 35463038 BACKGROUND

• Fiorelli S, Leopizzi G, Menna C, Teodonio L, Ibrahim M, Rendina EA, Ricci A, De Blasi RA, Rocco M, Massullo D. Ultrasound-Guided Erector Spinae Plane Block Versus Intercostal Nerve Block for Post-Minithoracotomy Acute Pain Management: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2020 Sep;34(9):2421-2429. doi: 10.1053/j.jvca.2020.01.026. Epub 2020 Jan 21.

  PMID: 32144056 BACKGROUND

• Taketa Y, Irisawa Y, Fujitani T. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after video-assisted thoracic surgery: a randomized controlled non-inferiority clinical trial. Reg Anesth Pain Med. 2019 Nov 8:rapm-2019-100827. doi: 10.1136/rapm-2019-100827. Online ahead of print.

  PMID: 31704789 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative; Thoracic Neoplasms

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• MARCO MAMMANA, MD, PhD

  PADUA UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Surgeon

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 15, 2023
• Study Start: April 5, 2023
• Primary Completion: August 15, 2024
• Study Completion: October 15, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)