The Efficacy of SPSIPB on Postoperative Pain and Analgesic Consumption in Patients Undergoing VATS

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Other: Serratus posterior superior intercostal plane block (SPSIPB)

• Registration Number: NCT05901103
• Lead Sponsor: Cumhuriyet University

Brief Summary

The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing video-assisted thoracoscopic surgery (VATS).

Detailed Description

There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All patients had standard general anesthesia. Group S had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated using patient-controlled analgesia (PCA) device.

Study Timeline

• Study Start: 2023-03-29
• Primary Completion: 2023-05-25
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-13
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult patients older than 18 years of age who underwent video-assisted thoracoscopic surgery (VATS) under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria

• Patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients undergoing open surgery,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPSIPB	Serratus posterior superior intercostal plane block (SPSIPB)	Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. PCA device was also performed to this group with the same protocol which was detailed in control arm.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS) scores	Postoperative 24 hours	Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
Total tramadol consumption	Postoperative 24 hours	Postoperative analgesic (tramadol) need is measured by using patient-controlled analgesia (PCA) device.

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Turkey