Cervical Erector Spinae Block for Shoulder Surgery

Study Overview
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Brief Summary
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Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life. In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. Erector spinae plane block (ESPB) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. Recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical ESPB (1). However, there are only few case reports related to efficiency and safety of this newly defined cervical ESPB technique (2) . The primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical ESPB for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone. Secondary objective is testing the safety of this newly defined block in terms of incidence of complications.

Detailed Description
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60 patients will be enrolled to in this study between June 2020 - October 2020. All patient will be randomly selected who will be operated for shoulder surgery. Age, weight, ASA score, body mass index, additional dissease status will be recorded. The patients will be divided in two groups. One group will have cervical ESPB before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 3/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Official Title
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Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery

Conditions
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Postoperative Pain, Shoulder Surgery

Intervention / Treatment
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* Other: Cervical erector spinae plane block
* Device: Intravenous morphine patient controlled analgesia device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 -65 years of agge ASA I-II Undergoing elective shoulder surgery Exclusion Criteria: infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs obesity (body mass index >35 kg/m2)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will randomized into two groups cervical ESP and control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Block group<br>Cervical Erector Spinae Plane Block administered group | Other: Cervical erector spinae plane block<br>* Cervical erector spinae plane block will be administered before the surgery<br>Device: Intravenous morphine patient controlled analgesia device<br>* 24 hour morphine consumption will be recorded<br>|
| Sham Comparator: Control group<br>Control group | Device: Intravenous morphine patient controlled analgesia device<br>* 24 hour morphine consumption will be recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded. | 24 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numering Rating Scale scores for pain | Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11- point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain | 24 hour | 
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting will be recorded | 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical erector spinae plane block, postoperative pain, Shoulder Surgery