Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection

Not Applicable

Completed

• Conditions: Video-Assisted; Paravertebral Block; Cryotherapy Effect; Thoracic Surgery
• Interventions: Procedure: Cryoanalgesia AND single-injection paravertebral block; Procedure: Single-injection paravertebral block

• Registration Number: NCT05896150
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.

Detailed Description

VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.

Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.

Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-09
• Study Start: 2023-11-09
• Status Verified: 2024-10
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-28
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer
• American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria

• Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space)
• Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia)
• Epidural analgesia preferred (high risk of thoracotomy, marginal lung function)
• Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)
• Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
• Preoperative thoracic or shoulder pain on the operated side
• History of thoracic surgery on the operated site
• Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)
• Inability to understand pain scales or to communicate clearly despite adequate teaching
• Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate < 60 mL/min, active gastric ulcer)
• Pregnancy
• Patient refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercostal cryoanalgesia AND single-injection paravertebral block	Cryoanalgesia AND single-injection paravertebral block	* Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery * Cryoanalgesia 5 cm lateral to the neuraxial, on the inferior costal border, CO2 at (-)50C to (-)70C for 2 minutes, repeated on 7 costal levels (T3-T9), after the lung resection and before chest closure.
Single-injection paravertebral block	Single-injection paravertebral block	-Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery

Primary Outcome Measures

Name	Time	Method
Acute thoracic pain during cough	24 hours	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)

Secondary Outcome Measures

Name	Time	Method
Incidence of vomiting related to opioid consumption	7 days	Evaluation for vomiting (yes or no)
QoR-15 score : 0 (worst) to 150 (best)	Preoperative and 48 hours postoperative	QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia
Time to hospital discharge	30 days	Total time between the end of surgery and prescription for hospital discharge
Evaluation of sedation related to opioid consumption	7 days	Using the Ramsay score (1 to 6)
Acute thoracic pain at rest	1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
Incidence of pruritus related to opioid consumption	7 days	Evaluation for pruritus (yes or no)
Acute thoracic pain during cough	1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
Postoperative morphine-equivalents consumption	7 days	Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily
Hypoesthesia over the ipsilateral thorax	24 hours	Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament
Incidence of nausea related to opioid consumption	7 days	Evaluation for nausea (yes or no)

Trial Locations

Locations (1)

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montréal, Quebec, Canada