The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Shoulder Surgery

NCT05901129 | Completed DMC

• 1 other identifier: SPSIPB on shoulder surgery
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Aim is to assess the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing shoulder surgery.

Conditions

Post Operative Pain

Keywords

serratus posterior superior intercostal plane block; postoperative pain; shoulder surgery; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total tramadol consumption

  Postoperative 24 hours

Study Arms (2)

SPSIPB

ACTIVE COMPARATOR

SPSIP 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, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. All patients had 3x400 mg ibuprofen intravenous (i.v.) in postoperative 24 hours. 50 mg tramadol was given as a rescue analgesic drug to the patients who had numerical rating scale (NRS) 4 or higher.

Other: Serratus posterior superior intercostal plane block (SPSIPB)

Control

NO INTERVENTION

Control group patients were not subjected to any block or local infiltration anesthesia (local anesthetic administration around the incision). Their postoperative pain was relieved with ibuprofen 3x400mg intravenous (i.v.) in postoperative 24 hours. The patients had NRS score 4 or higher were given 50 mg tramadol as a rescue analgesic.

Interventions

Serratus posterior superior intercostal plane block (SPSIPB) OTHER

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.

SPSIPB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

Location

Related 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.

  PMID: 36883093 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Oğuz Gündoğdu

  Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 13, 2023
• Study Start: March 29, 2023
• Primary Completion: May 25, 2023
• Study Completion: June 1, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)