Uniportal-VATS, Lung Resection Procedures, Locoregional Anesthesia, Post-operative Pain Management, Serratus Posterior Superior Intercostal Plane Block, Intercostal Nerve Block, Uniportal Video Assisted Thoracic Surgery
Conditions
Keywords
SPSIP block, ICN block, Uniportal-VATS
Brief summary
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane (SPSIP) block compared to the Intercostal Nerve (ICN) block for postoperative pain control, reduction of opioid analgesic consumption, minimization of postoperative respiratory complications, and enhancement of patient satisfaction (measured using the QoR-15 index) in patients undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal VATS).
Detailed description
Patients enrolled in the study will be divided into two groups: the SPSIP group and the ICN group. Patients in the SPSIP group will receive the Serratus Posterior Superior Intercostal Plane (SPSIP) block , while those in the ICN group will receive the Intercostal Nerve (ICN) block. Both blocks will be performed at the end of surgery: the SPSIP block will be administered by the attending anesthesiologist (Investigator 1) under ultrasound guidance immediately after skin closure and before extubation, while the ICN block will be performed by the surgeon under direct vision immediately before skin closure. All patients will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of surgery, during skin closure. Upon arrival in the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing an opioid-based solution. Patients reporting a Numeric Pain Rating Scale (NPRS) score greater than 4 during postoperative reassessments, despite PCA use, will be administered a rescue analgesic dose of 1000 mg of paracetamol (repeatable after 8 hours, with a maximum of 3000 mg in 24 hours). Postoperative pain intensity will be assessed by another investigator (Investigator 2) at 0, 2, 6, 12, and 24 hours after surgery using the NPRS, both at rest and during coughing. Total opioid consumption, rescue analgesic use, incidence of postoperative complications, and length of hospital stay will also be recorded. Twenty-four hours after surgery, Investigator 2 will administer the Quality of Recovery-15 (QoR-15) questionnaire to all patients. The responses will be used to calculate the QoR-15 index, summarizing overall patient satisfaction. Both patients and Investigator 2 will be blinded to the type of block administered, ensuring the study is conducted in a blinded manner.
Interventions
OTHERSPSIP block
While the patient is in the lateral decubitus position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of local anesthetic is administered superficially to the intercostal muscle.
OTHERICN block
The ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age with lung neoplasm who are candidates for pulmonary resection surgery via Uniportal-VATS * Patients who have provided informed consent to participate in the study
Exclusion criteria
* Patients who refuse to participate in the study by not signing the informed consent; * Patients with severe obesity (BMI \> 35), history of OSAS with or without CPAP; * Patients classified as ASA \> 3, according to the system established by the American Society of Anesthesiologists; * Patients unable to understand the use of the NPR Scale or the PCA device that will be used for postoperative analgesia; * Patients with allergies to analgesic and/or anesthetic drugs; * Patients undergoing anticoagulant therapy; * Patients with a history of chronic pain; * Patients with an infection at the site where SPSIPB or ICNB will be performed; * Patients with a history of thoracic surgery and/or thoracic trauma with rib fractures on the side of surgery; * Patients with chest wall deformities and/or neuromuscular diseases that interfere with normal ventilatory function. Additionally, patients whose surgical procedure is intraoperatively converted to an open pulmonary resection will be excluded post hoc from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | - immediately after the end of surgery; - 2 hours after the end of surgery; - 6 hours after the end of surgery; - 12 hours after the end of surgery; - 24 hours after the end of surgery. | The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid drug consumption | 24 hours after the end of surgery. | The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery |
| Consumption of rescue analgesics | 24 hours after the end of surgery. | The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours |
| postoperative respiratory complications | 24 hours after the end of surgery | The number of any postoperative respiratory complications in the two study groups |
| postoperative quality of recovery | 24 hours after surgery | The patient's level of satisfaction measured using the QoR-15 index, a numerical parameter calculated by administering the Quality of Recovery 15 (QoR-15) questionnaire..The QoR-15 score ranges from 0 to 150, with 0 indicating the poorest postoperative recovery quality and 150 the best |
| Length of Hospital Stay | from the end of surgery to the date of patient discharge, assessed up to 3 weeks | The duration of postoperative hospitalization |
Countries
Italy
Outcome results
None listed