Total Shoulder ArthroplastyNCT04855019
Post Surgical Pain in Arthroscopic Shoulder
A study testing shoulder periarticular injection, suprascapular and axillary nerve block in people with Total Shoulder Arthroplasty, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative multimodal analgesia methods occupy an essential place in modern anesthesia. The postoperative results of opioid analgesia are now at the bottom of the current problems due to its side effects. Longer-acting local anesthetics are now effective agents of analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- shoulder periarticular injection, suprascapular and axillary nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the age range of 18-65
- agree to participate in the study
Who cannot join
- diabetic patients
- chronic opioid use
- patients with sensitivity to local anesthetics
- patients with neuropathy
- Patients who cannot use the PCA
- cases returning to open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Namık Kemal University
Tekirdağ, Süleymanpaşa, 59100
About this study
Official title: Comparison of Combined Suprascapular and Axillary Nerve Blocks With Periarticular Injection for Analgesia in Arthroscopic Shoulder Surgery
Postoperative multimodal analgesia methods occupy an essential place in modern anesthesia. The postoperative results of opioid analgesia are now at the bottom of the current problems due to its side effects. Longer-acting local anesthetics are now effective agents of analgesia.
Investigators aimed to compare the two routine methods. Ultrasonic nerve blocks are the most important of multimodal analgesia in modern anesthesia. Suprascapular and axillary nerve blocks are routinely used as a safe method. It is a routine method used by periarticular local anesthetic surgeons.
İnvestigators decided to compare which method effectively follows these two methods with the postoperative 24 pain scale method.
Read the detailed description
This randomized trial aims to assess if a combined suprascapular-axillary nerve block (CSAB) to periarticular injection (PI) treated pain after arthroscopic shoulder surgery. Secondary endpoints included opioid consumption, discomfort associated with muscle weakness, and patient satisfaction.
sixty patients undergoing arthroscopic shoulder surgery will be randomized to receive ultrasound-guided CSAB (n = 30) or PI (n = 30). Pain intensity at rest and discomfort were recorded upon arrival in the recovery room, discharge to the ward, and at 4, 8, and 24 hours after surgery. Tramadol consumption was recorded for the first 24 hours. Patient satisfaction data will be recorded on the second postoperative day.
Using a computer-generated random allocation sequence (created by the study statistician), patients will randomly be assigned to ultrasound-guided SAB (n = 30) or PI(n = 30). Allocation numbers will be sealed in an opaque envelope opening in sequence by an independent anesthesiologist who will not assess outcomes. Outcome assessors will be blinded to treatment allocation.
After eligible patients are identified from the registry, patient charts were prospectively a blind orthopedist would collect data. Demographic data including sex, age, body mass index, surgical procedure, and complications will be recorded. Primary outcome measures were numeric rating scale pain scores and 24-hour postoperative opioid consumption. Pain scores will be recorded immediately before surgery, immediately following surgery in the postanesthesia recovery unit, and 24 hours postoperatively. Total opioid consumption will also be recorded for the first 24 hours following surgery. Secondary outcome measures included length of surgery, operating room time, perioperative anesthesia time, blood loss, hospital length of stay, and intraoperative and 30-day postoperative complication rates. Postoperative complications were further categorized as nerve-related, cardiopulmonary, and musculoskeletal (fracture or tendon rupture).
Statisticians will compare statistics between groups using a 2-sample t-test for normally distributed variables. The Wilcoxon rank-sum test will be used for non-normally distributed variables. A general linear model with correlated errors was used to account for repeated pain score assessments over time for each subject. The Fisher exact test will be used for categorical variables. Summary statistics will be reported as the mean and standard deviation for data analyzed using the 2-sample t-test and general linear models. The median and 25th and 75th percentiles will be reported for the Wilcoxon rank-sum test. The frequency (i.e., n) and percentage will be reported for data analyzed using the Fisher exact test. A P value of .05 will be designated as the threshold for statistical significance.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- shoulder periarticular injection, suprascapular and axillary nerve block
- Keywords
- shoulder arthroplasty, suprascapular block, axillary nerve block, periarticular injection, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder periarticular injection, suprascapular and axillary nerve blockProcedure or surgery
In the PI group, a mixture of 30 ml bupivacaine 0.5% and 30 ml saline solution will be injected by the orthopedist after the wound is closed.
In the CSAB group, a total of 20 ml 0.5% bupivacaine, 10 ml to the suprascapular notch, 10 ml to the axillary nerve, will be administered preoperatively by the anesthesiologist under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| periarticular injection group (PI) | Active comparator | the group to be given a periarticular injection by an orthopedist Receives: Procedure: shoulder periarticular injection, suprascapular and axillary nerve block |
| Combined suprascapular-axillary nerve block group (CSAB) | Active comparator | the group in which an anesthesiologist will perform combined suprascapular axillar border block under ultrasound guidance Receives: Procedure: shoulder periarticular injection, suprascapular and axillary nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline 11 point NRS (numeric rating Scala) Scala
Possible scores range from 0 (no pain) to 10 ( worst possible pain). Change for 24 Hours.
Measured: 0 to 24 hours
Total opioid consumption, from the moment of exit from the operation to the 24th hour
Each patient will be fitted with a patient controlled analgesia (PCA) device. The total tramadol requirement for both groups will be calculated.
Measured: 0 to 24 hours
Secondary outcomes (1)
nausea and vomiting
Data will be recorded in the postoperative period, in the form of present or not.
Measured: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start20 May 2021
- Primary completion15 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized trial, To compare the suprasacuplar-axillary nerve block combined with the periarticular injection method in shoulder arthroscopy cases.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayhan ŞAHİN, Namik Kemal University
- Investigators
- M.Cavidan ARAR, Study chair, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855019
- Sponsor's protocol ID
- Shoulder Surgery
- Status last verified
- Nov 2021
- First submitted
- 17 Apr 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Suprascapular and Axillary Nerve Blocks With Periarticular Injection for Analgesia in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04855019
- Acronym / sponsor ID
- Shoulder Surgery
- Conditions
- Total Shoulder Arthroplasty
- Keywords
- shoulder arthroplasty, suprascapular block, axillary nerve block, periarticular injection, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative multimodal analgesia methods occupy an essential place in modern anesthesia. The postoperative results of opioid analgesia are now at the bottom of the current problems due to its side effects. Longer-acting local anesthetics are now effective agents of analgesia.
Investigators aimed to compare the two routine methods. Ultrasonic nerve blocks are the most important of multimodal analgesia in modern anesthesia. Suprascapular and axillary nerve blocks are routinely used as a safe method. It is a routine method used by periarticular local anesthetic surgeons.
İnvestigators decided to compare which method effectively follows these two methods with the postoperative 24 pain scale method.
Detailed description
This randomized trial aims to assess if a combined suprascapular-axillary nerve block (CSAB) to periarticular injection (PI) treated pain after arthroscopic shoulder surgery. Secondary endpoints included opioid consumption, discomfort associated with muscle weakness, and patient satisfaction.
sixty patients undergoing arthroscopic shoulder surgery will be randomized to receive ultrasound-guided CSAB (n = 30) or PI (n = 30). Pain intensity at rest and discomfort were recorded upon arrival in the recovery room, discharge to the ward, and at 4, 8, and 24 hours after surgery. Tramadol consumption was recorded for the first 24 hours. Patient satisfaction data will be recorded on the second postoperative day.
Using a computer-generated random allocation sequence (created by the study statistician), patients will randomly be assigned to ultrasound-guided SAB (n = 30) or PI(n = 30). Allocation numbers will be sealed in an opaque envelope opening in sequence by an independent anesthesiologist who will not assess outcomes. Outcome assessors will be blinded to treatment allocation.
After eligible patients are identified from the registry, patient charts were prospectively a blind orthopedist would collect data. Demographic data including sex, age, body mass index, surgical procedure, and complications will be recorded. Primary outcome measures were numeric rating scale pain scores and 24-hour postoperative opioid consumption. Pain scores will be recorded immediately before surgery, immediately following surgery in the postanesthesia recovery unit, and 24 hours postoperatively. Total opioid consumption will also be recorded for the first 24 hours following surgery. Secondary outcome measures included length of surgery, operating room time, perioperative anesthesia time, blood loss, hospital length of stay, and intraoperative and 30-day postoperative complication rates. Postoperative complications were further categorized as nerve-related, cardiopulmonary, and musculoskeletal (fracture or tendon rupture).
Statisticians will compare statistics between groups using a 2-sample t-test for normally distributed variables. The Wilcoxon rank-sum test will be used for non-normally distributed variables. A general linear model with correlated errors was used to account for repeated pain score assessments over time for each subject. The Fisher exact test will be used for categorical variables. Summary statistics will be reported as the mean and standard deviation for data analyzed using the 2-sample t-test and general linear models. The median and 25th and 75th percentiles will be reported for the Wilcoxon rank-sum test. The frequency (i.e., n) and percentage will be reported for data analyzed using the Fisher exact test. A P value of .05 will be designated as the threshold for statistical significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized trial, To compare the suprasacuplar-axillary nerve block combined with the periarticular injection method in shoulder arthroscopy cases.
| Arm | Type | Receives |
|---|---|---|
| periarticular injection group (PI) | Active comparator | Procedure: shoulder periarticular injection, suprascapular and axillary nerve blockthe group to be given a periarticular injection by an orthopedist |
| Combined suprascapular-axillary nerve block group (CSAB) | Active comparator | Procedure: shoulder periarticular injection, suprascapular and axillary nerve blockthe group in which an anesthesiologist will perform combined suprascapular axillar border block under ultrasound guidance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being in the age range of 18-65
- agree to participate in the study
Key exclusion criteria (6 listed)
- diabetic patients
- chronic opioid use
- patients with sensitivity to local anesthetics
- patients with neuropathy
- Patients who cannot use the PCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shoulder periarticular injection, suprascapular and axillary nerve blockIn the PI group, a mixture of 30 ml bupivacaine 0.5% and 30 ml saline solution will be injected by the orthopedist after the wound is closed. In the CSAB group, a total of 20 ml 0.5% bupivacaine, 10 ml to the suprascapular notch, 10 ml to the axillary nerve, will be administered preoperatively by the anesthesiologist under ultrasound guidance. | Procedure or surgery | Combined suprascapular-axillary nerve block group (CSAB), periarticular injection group (PI) |
Primary outcome
Change from the baseline 11 point NRS (numeric rating Scala) Scala
Time frame: 0 to 24 hours
Possible scores range from 0 (no pain) to 10 ( worst possible pain). Change for 24 Hours.
Total opioid consumption, from the moment of exit from the operation to the 24th hour
Time frame: 0 to 24 hours
Each patient will be fitted with a patient controlled analgesia (PCA) device. The total tramadol requirement for both groups will be calculated.
1 secondary outcome
nausea and vomiting
Time frame: 0 to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Related trials for Total Shoulder Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Recruiting
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Reverse Shoulder Arthroplasty
Recruiting
INHANCE Stemless Reverse Shoulder IDE
Arthroplasty, Replacement
Enrolling by invitationObservational study
Subscapularis-Sparing Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Not yet recruiting
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Shoulder Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.Cavidan ARAR study chair
Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shoulder periarticular injection, suprascapular and axillary nerve block in people with Total Shoulder Arthroplasty, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline 11 point NRS (numeric rating Scala) Scala (time frame: 0 to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.