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

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 Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901129
• Other study ID #: SPSIPB on shoulder surgery
• Status: Completed
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2024
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

There were three randomized groups: Group 1 (no block-control group, n=12) Group 2 (SPSIPB-2nd rib targetted, n=12), Group 3 (SPSIPB-3rd rib targetted, n=12). All patients had standard general anesthesia. Group 2 and Group 3 had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) before the surgery. Local anesthetic was injected between 2nd rib an serratus posterior superior muscle in Group 2 and it was injected between 3rd rib and same muscle in Group 3. All patients had 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients had ibuprofen 3x400 mg in postoperative 24 hours. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol was administered as a rescue analgesic in all patients.Total tramadol consumption was calculated.

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 85 Years

Eligibility

Inclusion Criteria:

• 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.

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 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 total analgesic need was recorded as "milligram" in unit.	Postoperative 24 hours