Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery (cESPINas)
Primary Purpose
Pain, Acute, Opioid Use
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical ESP block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Age between 18-80
- ASA I-III
- Eligible for regional anesthesia
- Unilateral shoulder surgery
Exclusion Criteria:
- The patients who have clotting disorder
- Contra-endication for regional anesthesia
- Infection on the injection site
- Chronic opioid usage
- Previous same side shoulder surgery
- Severe COPD
- Diaphragmatic paralysis
- BMI 35 or over
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Cervical ESP block group
ISB Block group
Arm Description
Cervical ESP block will be performed as described by Elsharkawy at al. (7).
ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
Outcomes
Primary Outcome Measures
Opioid consumption
Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients
Secondary Outcome Measures
Postoperative pain scores
A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435236
Brief Title
Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery
Acronym
cESPINas
Official Title
Cervical Erector Spinae Plane Block Versus Interscalene Plexus Block for Pain Relief After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
Severe pain after arthroscopic surgery is a common experience for the patients . Different regional anesthetic technique has been applicated for postoperative pain relief . The main goal of regional anesthesia regarding postoperative pain relief is to reduce opioid requirements. The most commonly used approach is Interscalene brachial plexus block (ISB), since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery. Recently, a novel description of a T2-3 erector spinae plane (ESP) as an alternative to a BP block for an upper extremity surgical procedure. Following these studies, direct cervical ESP block has been recently performed successfully as both clinical and cadaveric study. The investigators hypothesized that cervical ESP block is as effective as (non-inferior) interscalene brachial plexus block in terms of postoperative analgesia of shoulder surgery. To evaluate the effectiveness of the cervical ESP block, the investigators have designed a randomized study. Primary aim is to evaluate the postoperative opioid consumption. Secondary aim is to evaluate postoperative pain scores by Numeric Rating Scale (0 to 10 point scale).
Detailed Description
This study has been designed as a prospective, randomized and single-blind trial. Local ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After obtaining the patients' written informed consents, we will include a total number of 94 patients (47 patients for each group). The inclusion criteria of the study was considered as age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for regional anesthesia, and unilateral shoulder surgery. The patients who have clotting disorder, contra-indication for regional anesthesia, infection on the injection site, chronic opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A computer-generated randomization program will be used to allocate the patient into two groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes will be blinded to the study groups of the patients. Both ISB block and cervical ESP block will be performed under ultrasound guidance in the block room preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical ESP block group
Arm Type
Active Comparator
Arm Description
Cervical ESP block will be performed as described by Elsharkawy at al. (7).
Arm Title
ISB Block group
Arm Type
Sham Comparator
Arm Description
ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
Intervention Type
Procedure
Intervention Name(s)
Cervical ESP block
Other Intervention Name(s)
ISB Block
Intervention Description
Cervical ESP block will be performed as described by Elsharkawy at al. (7). ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-80
ASA I-III
Eligible for regional anesthesia
Unilateral shoulder surgery
Exclusion Criteria:
The patients who have clotting disorder
Contra-endication for regional anesthesia
Infection on the injection site
Chronic opioid usage
Previous same side shoulder surgery
Severe COPD
Diaphragmatic paralysis
BMI 35 or over
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İlker İnce, MD
Phone
+905052949840
Email
ilkerince1983@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Aksoy, MD
Email
drmaksoy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlker İnce, MD
Organizational Affiliation
Ataturk University Anesthesiology Clinical Research Office
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Undecided
Citations:
PubMed Identifier
20565394
Citation
Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
Results Reference
background
PubMed Identifier
30966835
Citation
Demir U, Ince I, Aksoy M, Dostbil A, Ari MA, Sulak MM, Kose M, Tanios M, Ozmen O. The Effect of Pre-emptive Dexketoprofen Administration on Postoperative Pain Management in Patients with Ultrasound Guided Interscalene Block in Arthroscopic Shoulder Surgery. J Invest Surg. 2021 Jan;34(1):82-88. doi: 10.1080/08941939.2019.1576809. Epub 2019 Apr 9.
Results Reference
background
PubMed Identifier
9174311
Citation
Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.
Results Reference
background
PubMed Identifier
32044802
Citation
Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132. Erratum In: Anesthesiology. 2020 Apr 3;:null.
Results Reference
background
PubMed Identifier
29868941
Citation
Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
Results Reference
background
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
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Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery
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