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

Post Operative Pain Clinical Trial

Official title:

The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901103
• Other study ID #: SPSIP block on VATS
• Status: Completed
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale (NRS) scores	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.	Postoperative 24 hours
Secondary	Total tramadol consumption	Postoperative analgesic (tramadol) need is measured by using patient-controlled analgesia (PCA) device.	Postoperative 24 hours