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

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

Detailed Description
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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) before the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. Total tramadol consumption was calculated.

Official Title
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The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Shoulder Surgery

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Serratus posterior superior intercostal plane block (SPSIPB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPSIPB<br>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. PCA device was also performed to this group with the same protocol which was detailed in control arm. | Other: Serratus posterior superior intercostal plane block (SPSIPB)<br>* 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.<br>|
| No Intervention: Control<br>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 tramadol (intravenous analgesic drug) administration by using patient-controlled analgesia (PCA) device. Patient-controlled analgesia was achieved with tramadol hydrochloride at a concentration of 4 mg per 1 ml with the PCA device. The PCA device was configured to administer the patients boluses of 10 mg tramadol hydrochloride with a lockout time of 20 minutes, allowing a maximum of 4 pushes per hour. The total dose was standardized for all patients with a maximum daily dose of 400 mg and a maximum dose of 100 mg tramadol hydrochloride every 6 hours. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total tramadol consumption | Postoperative total analgesic need was recorded as milligram in unit. | Postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serratus posterior superior intercostal plane block, postoperative pain, shoulder surgery, regional anesthesia