Cervical Erector Spinae Block for Shoulder Surgery

Postoperative Pain Clinical Trial

Official title:

Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04397549
• Other study ID #: ATA-173
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: May 2020
• Source: Konya Necmettin Erbakan Üniversitesi
• Contact: Alper Kilicaslan, MD, Assoc.Prof
• Phone: 905053780376
• Email: dralperkilicaslan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 15, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Shoulder Surgery

Intervention

Other:
• Cervical erector spinae plane block
Cervical erector spinae plane block will be administered before the surgery

Device:
• Intravenous morphine patient controlled analgesia device
24 hour morphine consumption will be recorded

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Konya

Sponsors (2)

Lead Sponsor	Collaborator
Konya Necmettin Erbakan Üniversitesi	Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Apr 21. pii: rapm-2019-101154. doi: 10.1136/rapm-2019-101154. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting will be recorded	24 hour