Pain, PostoperativeNCT04947007
Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
A study testing Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection, Bupivacaine HCl 0.025 % in 10+10 ML Injection and Bupivacaine HCl 0.025 % in 5+5 ML Injection in people with Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection, Bupivacaine HCl 0.025 % in 10+10 ML Injection and Bupivacaine HCl 0.025 % in 5+5 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 1 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for total shoulder arthroscopy surgery
- Patients with American Society of Anesthesiology (ASA) Class 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- 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
- Keywords
- suprascapular nerve block, axillary nerve block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML InjectionDrug
Also called Marcaine
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.
Bupivacaine HCl 0.025 % in 10+10 ML InjectionDrug
Also called Marcaine
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.
Bupivacaine HCl 0.025 % in 5+5 ML InjectionDrug
Also called Marcaine
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.
Isotonic solutionDrug
Also called serum physiologic
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic. Receives: Drug: Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection |
| Group 2 | Active comparator | In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic. Receives: Drug: Bupivacaine HCl 0.025 % in 10+10 ML Injection |
| Group 3 | Active comparator | In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic. Receives: Drug: Bupivacaine HCl 0.025 % in 5+5 ML Injection |
| Group 4 | Active comparator | In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic. Receives: Drug: Isotonic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (0-10) pain scores for patients
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
Measured: 48 hours
Secondary outcomes (1)
Opioid (mg) consumption
Opioid (mg) consumption
Measured: postoperative period up to 48th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start15 Jul 2021
- Primary completion21 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Nil R Kirsan, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947007
- Sponsor's protocol ID
- 2020/1830
- Status last verified
- Mar 2022
- First submitted
- 24 Jun 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32975624Ozkan 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.
PubMed 32030694Price 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.
PubMed 27997490Marty 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.
PubMed 28207648
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
- ClinicalTrials.gov ID
- NCT04947007
- Acronym / sponsor ID
- 2020/1830
- Conditions
- Pain, Postoperative
- Keywords
- suprascapular nerve block, axillary nerve block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Jul 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML InjectionIn this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic. |
| Group 2 | Active comparator | Drug: Bupivacaine HCl 0.025 % in 10+10 ML InjectionIn this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic. |
| Group 3 | Active comparator | Drug: Bupivacaine HCl 0.025 % in 5+5 ML InjectionIn this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic. |
| Group 4 | Active comparator | Drug: Isotonic solutionIn this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for total shoulder arthroscopy surgery
- Patients with American Society of Anesthesiology (ASA) Class 1-3
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML InjectionAlso: MarcaineIn 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. | Drug | Group 1 |
| Bupivacaine HCl 0.025 % in 10+10 ML InjectionAlso: MarcaineIn 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. | Drug | Group 2 |
| Bupivacaine HCl 0.025 % in 5+5 ML InjectionAlso: MarcaineIn 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. | Drug | Group 3 |
| Isotonic solutionAlso: serum physiologicIn this group, US guided suprascapulary and axillary block will be performed with isotonic solution | Drug | Group 4 |
Primary outcome
Visual Analogue Scale (0-10) pain scores for patients
Time frame: 48 hours
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
1 secondary outcome
Opioid (mg) consumption
Time frame: postoperative period up to 48th 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 Mar 2022.
- Background: PubMed 32975624Lee 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.
- Background: PubMed 32030694Ozkan 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.
- Background: PubMed 27997490Price 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.
- Background: PubMed 28207648Marty 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.
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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.
Nil R Kirsan, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection, Bupivacaine HCl 0.025 % in 10+10 ML Injection and Bupivacaine HCl 0.025 % in 5+5 ML Injection in people with Pain, Postoperative, run by Istanbul 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 5 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 Mar 2022. 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?
Visual Analogue Scale (0-10) pain scores for patients (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947007, which also lists 4 linked publications.
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 Mar 2022.