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Cervical Erector Spinae Block for Shoulder Surgery

Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04397549
Enrollment
60
Registered
2020-05-21
Start date
2020-06-15
Completion date
2020-10-15
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Shoulder Surgery

Keywords

cervical erector spinae plane block, postoperative pain, Shoulder Surgery

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.

Interventions

Cervical erector spinae plane block will be administered before the surgery

24 hour morphine consumption will be recorded

Sponsors

Ataturk University
CollaboratorOTHER
Konya Necmettin Erbakan Üniversitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Patients will randomized into two groups cervical ESP and control.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumption24 hour postoperativelyAll patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.

Secondary

MeasureTime frameDescription
Numering Rating Scale scores for pain24 hourNumeric 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
Postoperative nausea and vomiting24 hourIncidence of postoperative nausea and vomiting will be recorded

Countries

Turkey (Türkiye)

Contacts

Primary ContactAlper Kilicaslan, MD, Assoc.Prof
dralperkilicaslan@gmail.com905053780376
Backup ContactIlker Ince
ilkerince1983@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026