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

Not Applicable

Completed

• Conditions: Post Operative Pain

• Registration Number: NCT05901129
• Lead Sponsor: Cumhuriyet University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-03-29
• Primary Completion: 2023-05-25
• Study Completion: 2023-06-01
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 total analgesic need was recorded as "milligram" in unit.

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Turkey