NCT04397549

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 15, 2020

Last Update Submit

May 20, 2020

Conditions

Postoperative PainShoulder Surgery

Keywords

cervical erector spinae plane blockpostoperative painShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Numering Rating Scale scores for pain

    24 hour

  • Postoperative nausea and vomiting

    24 hour

Study Arms (2)

Block group

ACTIVE COMPARATOR

Cervical Erector Spinae Plane Block administered group

Other: Cervical erector spinae plane blockDevice: Intravenous morphine patient controlled analgesia device

Control group

SHAM COMPARATOR

Control group

Device: Intravenous morphine patient controlled analgesia device

Interventions

Cervical erector spinae plane blockOTHER

Cervical erector spinae plane block will be administered before the surgery

Block group
Intravenous morphine patient controlled analgesia deviceDEVICE

24 hour morphine consumption will be recorded

Block groupControl group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of agge
  • ASA I-II
  • Undergoing elective shoulder surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 31161549BACKGROUND

  • 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.

    PMID: 32321860RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alper Kilicaslan, MD, Assoc.Prof

    Necmettin Erbakan University Meram Medical Faculty

    PRINCIPAL INVESTIGATOR

  • İlker İnce, MD, Assoc.Prof

    Ataturk University Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alper Kilicaslan, MD, Assoc.Prof

CONTACT

905053780376dralperkilicaslan@gmail.com

Ilker Ince

CONTACT

ilkerince1983@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Patients will randomized into two groups cervical ESP and control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assoc.Professor

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 21, 2020

Study Start

June 15, 2020

Primary Completion

September 30, 2020

Study Completion

October 15, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

TU(1)