Cervical Erector Spinae Block for Shoulder Surgery

Not Applicable

• Conditions: Shoulder Surgery; Postoperative Pain
• Interventions: Other: Cervical erector spinae plane block; Device: Intravenous morphine patient controlled analgesia device

• Registration Number: NCT04397549
• Lead Sponsor: Konya Necmettin Erbakan Üniversitesi

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-20
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-22
• Study Start: 2020-06-15
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Block group	Intravenous morphine patient controlled analgesia device	Cervical Erector Spinae Plane Block administered group
Block group	Cervical erector spinae plane block	Cervical Erector Spinae Plane Block administered group
Control group	Intravenous morphine patient controlled analgesia device	Control group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	24 hour	Incidence of postoperative nausea and vomiting will be recorded
Numering Rating Scale scores for pain	24 hour	Numeric 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

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey