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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Shoulder Surgery
• Intervention / Treatment: Other: Cervical erector spinae plane block; Device: Intravenous morphine patient controlled analgesia device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block group; Cervical Erector Spinae Plane Block administered group	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
Sham Comparator: Control group	Device: Intravenous morphine patient controlled analgesia device; 24 hour morphine consumption will be recorded

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi
• Collaborators: Ataturk University
• Investigators: Principal Investigator: Alper Kilicaslan, MD, Assoc.Prof, Necmettin Erbakan University Meram Medical Faculty; Principal Investigator: İlker İnce, MD, Assoc.Prof, Ataturk University Medical Faculty

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 15, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; Shoulder Surgery; cervical erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: ATA-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No