Cervical Erector Spinae Block for Shoulder Surgery

Konya Necmettin Erbakan Üniversitesi

Status: Unknown

Conditions: Postoperative Pain; Shoulder Surgery

Treatments: Other: Cervical erector spinae plane block; Device: Intravenous morphine patient controlled analgesia device

Study type: Interventional

Funder types: Other

Identifiers

NCT04397549

ATA-173

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Block group

Active Comparator group

Description:

Cervical Erector Spinae Plane Block administered group

Treatment:

Other: Cervical erector spinae plane block

Device: Intravenous morphine patient controlled analgesia device

Control group

Sham Comparator group

Description:

Control group

Treatment:

Device: Intravenous morphine patient controlled analgesia device