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Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection
Bupivacaine HCl 0.025 % in 10+10 ML Injection
Bupivacaine HCl 0.025 % in 5+5 ML Injection
Isotonic solution
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring suprascapular nerve block, axillary nerve block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for total shoulder arthroscopy surgery
  • Patients with American Society of Anesthesiology (ASA) Class 1-3

Exclusion Criteria:

  • Refusal of regional anesthesia
  • Infection on the local anesthetic application area
  • Patients with known coagulopathy
  • Known allergy against local anesthetics
  • Anatomical difficulties to perform supra scapular and axillary blocks

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.

In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.

In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.

In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (0-10) pain scores for patients
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')

Secondary Outcome Measures

Opioid (mg) consumption
Opioid (mg) consumption

Full Information

First Posted
June 24, 2021
Last Updated
March 1, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04947007
Brief Title
Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
Official Title
Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.
Detailed Description
The investigators research was designed as a single-center, prospective, randomized double-blind study. After the approval of the Ethics Committee, the study will start and is aimed to be completed in 6 months. The patients consecutively undergoing shoulder arthroscopy surgery in Istanbul University Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study. Preoperative evaluation of the patients will include detailed history, demographic and clinical parameters including gender, age, indication for shoulder arthroscopy, creatinine, chronic disease history will be recorded. Patients will be taken to the operating room after premedication with 2 mg midazolam and 50 mg fentanyl. Patients will be monitored for rhythm, blood oxygen and pressure in the operating room. Ultrasonography (USG) guided suprascapular and axillary block will be performed. Suprascapular and axillary block will be done for postoperative analgesia. After the block is done, general anesthesia will be applied. In this study there will be four groups with the control group included. For the first group 15cc+15cc , for the second group 10cc+10cc for the third group 5cc+5cc of local anesthetic will be injected. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patients will be followed up for 48 hours postoperatively in routine practice. They will be observed for postoperative nausea and vomiting, first mobilisation time, lenght of hospital stay, analgesic consumption and surgent and patient satisfaction. Before the study, it was determined that at least 132 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, statistical analysis will be performed with Statistical Package for the Social Sciences (SPSS). The investigators study does not contain any modifications other than the investigators daily routine practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
suprascapular nerve block, axillary nerve block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl 0.025 % in 10+10 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl 0.025 % in 5+5 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Isotonic solution
Other Intervention Name(s)
serum physiologic
Intervention Description
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Primary Outcome Measure Information:
Title
Visual Analogue Scale (0-10) pain scores for patients
Description
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Opioid (mg) consumption
Description
Opioid (mg) consumption
Time Frame
postoperative period up to 48th hours.
Other Pre-specified Outcome Measures:
Title
Time of onset of narcotic analgesic need
Description
(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
Time Frame
postoperative period up to 48th hours.
Title
Incidence of side effects
Description
Incidence of nausea and vomiting
Time Frame
postoperative period up to 48th hour
Title
Time until postoperative first mobilization
Description
First mobilization time
Time Frame
Up to 48 hours
Title
Length of hospital stay
Description
Hospitalization
Time Frame
Through study completion, an average of 1 week
Title
Patient satisfaction
Description
Satisfaction score; 0- very unsatisfied, 3- very satisfied
Time Frame
postoperative period up to 48th hours and postoperative in the first month
Title
Surgeon satisfaction
Description
Satisfaction score; 0- very unsatisfied, 3- very satisfied
Time Frame
postoperative period up to 48th hours and postoperative in the first month

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: Patients scheduled for total shoulder arthroscopy surgery Patients with American Society of Anesthesiology (ASA) Class 1-3 Exclusion Criteria: Refusal of regional anesthesia Infection on the local anesthetic application area Patients with known coagulopathy Known allergy against local anesthetics Anatomical difficulties to perform supra scapular and axillary blocks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nil R Kirsan, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32975624
Citation
Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
Results Reference
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PubMed Identifier
32030694
Citation
Ozkan D, Cemaloglu S, Catma FM, Akkaya T. Effects of suprascapular and axillary nerve block on postoperative pain relief sevoflurane consumption and visual clarity in arthroscopic shoulder surgery. Agri. 2020 Jan;32(1):1-7. doi: 10.14744/agri.2019.04875.
Results Reference
background
PubMed Identifier
27997490
Citation
Price D. Optimizing the Combined Suprascapular and Axillary Nerve (SSAX) Block. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):122. doi: 10.1097/AAP.0000000000000518. No abstract available.
Results Reference
background
PubMed Identifier
28207648
Citation
Marty P, Rontes O, Delbos A. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Block: Interpret With Caution. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):273-274. doi: 10.1097/AAP.0000000000000551. No abstract available.
Results Reference
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Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

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