Clinical trial NCT04397549: Cervical Erector Spinae Block for Shoulder Surgery
Official title: Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Shoulder Surgery
Keywords: cervical erector spinae plane block
postoperative pain
Shoulder Surgery
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2020-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will randomized into two groups cervical ESP and control.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Numering Rating Scale scores for pain
timeFrame: 24 hour
measure: Postoperative nausea and vomiting
timeFrame: 24 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University Meram Medical Faculty
name: Alper Kilicaslan, MD, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University Medical Faculty
name: İlker İnce, MD, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.