Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.

Disqualifiers

Patients who refuse to participate in the study by not signing the informed consent;

Patients with myasthenia gravis, severe obesity (BMI > 35), history of OSAS with or without CPAP;

Patients belonging to ASA classes > 3, according to the system developed by the American Society of Anesthesiologists;

Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine

    Procedure/Surgery

    While the patient is in the prone or the sitting 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 0.25% bupivacaine is administered superficially to the intercostal muscle.

  • Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)

    Procedure/Surgery

    While the patient is in the prone or the sitting 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 0.9% NaCl is administered superficially to the intercostal muscle

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: SPSIP groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity

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.

Time frame
0, 2, 6, 12, and 24 hours after the end of the surgical procedure

Secondary outcomes

1

Total opioid drug consumption

The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery

Time frame
24 hours after surgery
2

Consumption of rescue analgesics

The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours

Time frame
24 hours after surgery
3

postoperative respiratory complications

The number of any postoperative respiratory complications in the two study groups

Time frame
24 hours after surgery
4

postoperative quality of recovery

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 to the patient

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.