Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies

Pain, Postoperative Clinical Trial

Official title:

Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423677
• Other study ID #: Serratus Posterior Superior
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Engin ihsan Turan
• Phone: +9005382431114
• Email: enginihsan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner.

Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Obtaining consent from the patient and their relative

• ASA score of I-II

• No bleeding diathesis

• No history of anticoagulant use

• No history of neuropathic diseases such as Diabetes Mellitus

• Patients aged 18-65 years undergoing shoulder arthroscopy surgery

Exclusion Criteria:

• Lack of consent from the patient or their relative

• Patients with an ASA score of III or above

• Patients with a history of bleeding diathesis

• Conditions where regional anesthesia is contraindicated

• Patients with a history of neuropathic diseases

• Patients under 18 years or over 65 years of age

• Patients with a history of allergies to the aforementioned medications

• Patients with an infection at the site where the block will be administered

Related Conditions & MeSH terms

• Block
• Pain, Postoperative
• Shoulder Pain

Intervention

Procedure:
• Serratus Posterior Superior Intercostal Plane Block
The Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner.

Device:
• patient controlled analgesia
intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours

Locations

Country	Name	City	State
Turkey	Health Science University Istanbul Kanuni Sultan Süleyman Education and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale score	Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.	0, 1, 6, 12, and 24 hours
Primary	opioid consumption	Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.	0, 1, 6, 12, and 24 hours