Cervical Erector Spinae Block for Shoulder Surgery
Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Konya、七面鳥
- Necmettin Erbakan University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Block group
Cervical Erector Spinae Plane Block administered group
|
Cervical erector spinae plane block will be administered before the surgery
24 hour morphine consumption will be recorded
|
|
偽コンパレータ：Control group
|
24 hour morphine consumption will be recorded
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Morphine consumption
時間枠：24 hour postoperatively
|
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
|
24 hour postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numering Rating Scale scores for pain
時間枠：24 hour
|
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
時間枠：24 hour
|
Incidence of postoperative nausea and vomiting will be recorded
|
24 hour
|
協力者と研究者
捜査官
- 主任研究者：Alper Kilicaslan, MD, Assoc.Prof、Necmettin Erbakan University Meram Medical Faculty
- 主任研究者：İlker İnce, MD, Assoc.Prof、Ataturk University Medical Faculty
出版物と役立つリンク
一般刊行物
- Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
- Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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