Back to resultsEffect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
Primary Purpose
Shoulder Surgery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
interscalene brachial plexus block
suprascapular nerve block
Group Control
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Surgery focused on measuring suprascapular nerve block, interscalene brachial plexus block, ultrasound, patient satisfaction score, analgesic consumption
Eligibility Criteria
Inclusion Criteria:
- ASA I- ASA II Patients
Exclusion Criteria:
- history of allergy to the study medication
- refusal to participate
Sites / Locations
- Sibel Seçkin Pehlivan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group IPSB
Group SSNB
Group Control
Arm Description
In the first group of patients (Group IPSB), ultrasound-guided interscalene brachial plexus block will be applied 30 minutes before surgery.
In the second group of patients, ultrasound-guided interscalene brachial plexus block and suprascapular nerve block will be applied 30 minutes before surgery.
Patients in the third group (Group C), will be considered the control group and no block will be performed.
Outcomes
Primary Outcome Measures
Verbal Analogue Scores
A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome.
opioid consumption
In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded.
Secondary Outcome Measures
Complications of the procedures
The complications of the intervations will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04769570
Brief Title
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
Official Title
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes 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
In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.
Detailed Description
General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Surgery
Keywords
suprascapular nerve block, interscalene brachial plexus block, ultrasound, patient satisfaction score, analgesic consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group IPSB
Arm Type
Active Comparator
Arm Description
In the first group of patients (Group IPSB), ultrasound-guided interscalene brachial plexus block will be applied 30 minutes before surgery.
Arm Title
Group SSNB
Arm Type
Active Comparator
Arm Description
In the second group of patients, ultrasound-guided interscalene brachial plexus block and suprascapular nerve block will be applied 30 minutes before surgery.
Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
Patients in the third group (Group C), will be considered the control group and no block will be performed.
Intervention Type
Procedure
Intervention Name(s)
interscalene brachial plexus block
Intervention Description
Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
suprascapular nerve block
Intervention Description
Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Group Control
Intervention Description
consist of the patient group without any procedure.
Primary Outcome Measure Information:
Title
Verbal Analogue Scores
Description
A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome.
Time Frame
24 hours after surgery
Title
opioid consumption
Description
In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Complications of the procedures
Description
The complications of the intervations will be recorded
Time Frame
During the blocks and 24 hours after surgery
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:
ASA I- ASA II Patients
Exclusion Criteria:
history of allergy to the study medication
refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Pehlivan, MD
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibel Seçkin Pehlivan
City
Kayseri
State/Province
Talas
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De- identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 24 months of study completion.
IPD Sharing Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.
Citations:
PubMed Identifier
22792099
Citation
Bowens C Jr, Sripada R. Regional blockade of the shoulder: approaches and outcomes. Anesthesiol Res Pract. 2012;2012:971963. doi: 10.1155/2012/971963. Epub 2012 Jun 25.
Results Reference
result
PubMed Identifier
26688821
Citation
Chen HP, Shen SJ, Tsai HI, Kao SC, Yu HP. Effects of Interscalene Nerve Block for Postoperative Pain Management in Patients after Shoulder Surgery. Biomed Res Int. 2015;2015:902745. doi: 10.1155/2015/902745. Epub 2015 Nov 24.
Results Reference
result
PubMed Identifier
31361631
Citation
Cabaton J, Nove-Josserand L, Mercadal L, Vaudelin T. Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study. Eur J Anaesthesiol. 2019 Oct;36(10):778-786. doi: 10.1097/EJA.0000000000001065.
Results Reference
result
Learn more about this trial
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
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