Cervical Erector Spinae Block for Shoulder Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2020-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will randomized into two groups cervical ESP and control.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Block group

Cervical Erector Spinae Plane Block administered group

Group Type ACTIVE_COMPARATOR

Cervical erector spinae plane block

Intervention Type OTHER

Cervical erector spinae plane block will be administered before the surgery

Intravenous morphine patient controlled analgesia device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Control group

Group Type SHAM_COMPARATOR

Intravenous morphine patient controlled analgesia device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Interventions

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Cervical erector spinae plane block

Cervical erector spinae plane block will be administered before the surgery

Intervention Type OTHER

Intravenous morphine patient controlled analgesia device

24 hour morphine consumption will be recorded

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No