Cervical Erector Spinae Block for Shoulder Surgery
Primary Purpose
Postoperative Pain, Shoulder Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical erector spinae plane block
Intravenous morphine patient controlled analgesia device
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring cervical erector spinae plane block, postoperative pain, Shoulder Surgery
Eligibility Criteria
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)
Sites / Locations
- Necmettin Erbakan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Block group
Control group
Arm Description
Cervical Erector Spinae Plane Block administered group
Control group
Outcomes
Primary Outcome Measures
Morphine consumption
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
Secondary Outcome Measures
Numering Rating Scale scores for pain
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
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded
Full Information
NCT ID
NCT04397549
First Posted
May 15, 2020
Last Updated
May 20, 2020
Sponsor
Konya Necmettin Erbakan Üniversitesi
Collaborators
Ataturk University
1. Study Identification
Unique Protocol Identification Number
NCT04397549
Brief Title
Cervical Erector Spinae Block for Shoulder Surgery
Official Title
Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi
Collaborators
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Surgery
Keywords
cervical erector spinae plane block, postoperative pain, Shoulder Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will randomized into two groups cervical ESP and control.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Block group
Arm Type
Active Comparator
Arm Description
Cervical Erector Spinae Plane Block administered group
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Cervical erector spinae plane block
Intervention Description
Cervical erector spinae plane block will be administered before the surgery
Intervention Type
Device
Intervention Name(s)
Intravenous morphine patient controlled analgesia device
Intervention Description
24 hour morphine consumption will be recorded
Primary Outcome Measure Information:
Title
Morphine consumption
Description
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
Numering Rating Scale scores for pain
Description
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
Time Frame
24 hour
Title
Postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting will be recorded
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alper Kilicaslan, MD, Assoc.Prof
Phone
905053780376
Email
dralperkilicaslan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ilker Ince
Email
ilkerince1983@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alper Kilicaslan, MD, Assoc.Prof
Organizational Affiliation
Necmettin Erbakan University Meram Medical Faculty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İlker İnce, MD, Assoc.Prof
Organizational Affiliation
Ataturk University Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alper kılıcaslan, prof
Phone
905053780376
Email
dralperkilicaslan@gmail.com
First Name & Middle Initial & Last Name & Degree
ilker ince, prof
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31161549
Citation
Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
Results Reference
background
PubMed Identifier
32321860
Citation
Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
Results Reference
result
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Cervical Erector Spinae Block for Shoulder Surgery
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