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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Konya, Kalkon
- Necmettin Erbakan University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Sham Comparator: Control group
|
24 hour morphine consumption will be recorded
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Morphine consumption
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numering Rating Scale scores for pain
Tidsram: 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
Tidsram: 24 hour
|
Incidence of postoperative nausea and vomiting will be recorded
|
24 hour
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Alper Kilicaslan, MD, Assoc.Prof, Necmettin Erbakan University Meram Medical Faculty
- Huvudutredare: İlker İnce, MD, Assoc.Prof, Ataturk University Medical Faculty
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ATA-173
Plan för individuella deltagardata (IPD)
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