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Clinical Trials/NCT04397549
NCT04397549
Unknown
Not Applicable

Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery

Konya Necmettin Erbakan Üniversitesi1 site in 1 country60 target enrollmentJune 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Konya Necmettin Erbakan Üniversitesi
Enrollment
60
Locations
1
Primary Endpoint
Morphine consumption
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2020
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Konya Necmettin Erbakan Üniversitesi
Responsible Party
Principal Investigator
Principal Investigator

Alper Kilicaslan

MD, Assoc.Professor

Konya Necmettin Erbakan Üniversitesi

Eligibility Criteria

Inclusion Criteria

  • 18 -65 years of agge
  • 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)

Outcomes

Primary Outcomes

Morphine consumption

Time Frame: 24 hour postoperatively

All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.

Secondary Outcomes

  • Postoperative nausea and vomiting(24 hour)
  • Numering Rating Scale scores for pain(24 hour)

Study Sites (1)

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