Shoulder PainNCT05241977
MINIMUM EFFECTIVE VOLUME OF BUPIVACAİNE FOR ANTERIOR SUPRASCAPULAR NERVE BLOCK
An observational study of Shoulder Pain and Supraspinatus Tendinitis, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Various local anesthetic volumes are used in the literature for anterior suprascapular nerve block (ASSB). There are different studies between 15 ml and 5 ml. Effective local anesthetic volume studies for ASSB have not yet been performed. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Supraspinatus Tendinitis, Bankart Lesions
- What is being tested?
- anterior supra scapular nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2022to 13 Jul 2022
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age greater than 18 years with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery patients under general anesthesia.
Who may be able to join
- adults (age greater than 18 yr) with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery under general anesthesia
Who cannot join
- dementia
- chronic opioid consumption
- chronic pain disease
- chronic obstructive pulmonary disease
- history of serious lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MINIMUM EFFECTIVE AND MAXIMUM DIAPHRAGM-SPARING VOLUME OF BUPIVACAİNE FOR ULTRASOUND GUIDED ANTERIOR SUPRASCAPULAR NERVE BLOCK
Various local anesthetic volumes are used in the literature for anterior suprascapular nerve block (ASSB). There are different studies between 15 ml and 5 ml. Effective local anesthetic volume studies for ASSB have not yet been performed. Our study is aimed to investigate the minimum effective local anesthetic volume for ASSB.
Read the detailed description
Peripheral nerve blockade reduces pain scores and opioid consumption and increases patient satisfaction within the first 24 h after shoulder surgery. In the absence of neuraxial and peripheral nerve blocks, opioid consumption after shoulder surgery has been purported to rival the one recorded for thoracotomy. Interscalene brachial plexus blocks (ISBB) constitute the gold standard for analgesia after shoulder procedures. Compared with parenteral opioids, ISBB results in lower pain scores improved patient satisfaction [4]. ISBB is highly utilized in clinical practice as it provides anesthesia and analgesia to the shoulder and lateral aspects of the arm and the forearm, reducing opioid consumption and subsequent opioid-related adverse effects [5]. However, ISB is associated with numerous complications and adverse effects3 such as phrenic nerve palsy (100%), recurrent laryngeal nerve block (3 - 21%), stellate ganglion block (5 - 75%) (Horner's syndrome), spinal (0.4 - 4%) and epidural anesthesia (2.2%), and convulsions (0.2 - 3%) at standard volumes of 20 - 30 ml. Phrenic nerve block is associated with significant reductions in ventilatory function including a 21 - 34% decrease in forced vital capacity (FVC), 17 - 37% decrease in forced expiratory volume, and 15.4% decrease in peak expiratory flow rate. The most common adverse effect after ISB remains the occurrence of ipsilateral phrenic nerve block. Although well tolerated by healthy subjects, HDP becomes a prohibitive risk for patients with pulmonary pathology, who may be unable to withstand the 30% reduction in FVC. Viable diaphragm-sparing alternatives to ISB should achieve three separate and distinct goals: adequate surgical anesthesia (without general anesthesia), adequate postoperative analgesia, and low incidence of HDP. Alternative nerve blocks are performed in shoulder surgery to prevent HDP. Therefore, different approaches such as suprascapular nerve block, costoclavicular block, shoulder block, supraclavicular block, combined infraclavicular and suprascapular block, which are defined as diaphragm sparing blocks, are recommended.
Our study aimed to investigate the minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing. Our secondary aim is to reveal an important parameter in the diaphragm sparing nerve blocks. The volume of a local anesthetic to be administered should be expected to have a common volume that is the most effective and protects the diaphragm. We envisioned that this should be defined as the minimum target-specific volume (MTsV).
Adults (over 18 years of age) with the American Society of Anesthesiologists Physical Condition classification I to III who are scheduled to undergo unilateral ambulatory arthroscopic shoulder surgery under general anesthesia will be included in the study. Written informed consent will be obtained from all study subjects before participation in this study. Surgical procedures are planned to include shoulder arthroscopy, rotator cuff repair, acromioplasty, Bankart repair, and superior labrum anterior-posterior repair. Patients with a history of serious broncho-pulmonary disease, known phrenic nerve pathology, existing neurological deficits or neuropathy involving the brachial plexus on the surgical side, contraindications to nerve blocks (infection, bleeding diathesis, allergy to local anesthetics), or history will be excluded from the study. A full pre-operative evaluation will be performed with the necessary laboratories the day before the surgery, and written informed consent will be obtained.
The 0.5% initial injected volume of bupivacaine was 10 mL, providing a complete sensory block of anterior suprascapular nerve block based on our clinical experience. According to the Dixon and Massey [10] up-down method, the 0.5% bupivacaine volume used for a given patient was determined by the result of the previous block, as defined above as block success. Once effective ASSB is achieved, the volume of bupivacaine 0.5% to the next patient will be reduced by 1 mL. Conversely, in case of block failure, the volume of 0.5% bupivacaine will be increased by 1 mL in the next patient.
An independent observer will assess ipsilateral hemidiaphragmatic motion by real-time M-mode ultrasonography using a 1 to 5 MHz broadband phased array US probe (Philips CX50). Patients were examined in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as the acoustic window. The range of diaphragm movement from the resting expiratory position to deep inspiration (sigh test) and the range of diaphragm movement from the resting expiratory position when quickly inhaling through the nose (sniffing test) will be recorded. More than 75% hemidiaphragmatic movement reduction, no movement, or paradoxical movement will be considered complete paresis. Between 25% and 75%, hemidiaphragmatic movement decrease was considered partial paresis, and less than 25% hemidiaphragmatic movement decrease paresis was considered absent. The movement of the diaphragm will be measured in centimeters. The normal caudal movement was positive (+), paradoxical head movement was negative (-). Each test will be performed three times, and the values will be averaged. All measurements will be made before (beginning) and 30 minutes after the block.
Fifty minutes after the block performance, general anesthesia will be given using a standard protocol of intravenously administered propofol 2 mg/kg, Fentanyl 1 ug/kg, and rocuronium 0.6 mg/kg. Pain scores of the patients will be recorded for 48 hours postoperatively.
- Conditions
- Shoulder Pain, Supraspinatus Tendinitis, Bankart Lesions
- Being tested
- anterior supra scapular nerve block
- Keywords
- regional anesthesia, shoulder arthroscopy, ortopaedic anesthesia, brachial plexus blocks, diaphragm sparing nerve blocks
- Medical subject headings
- Shoulder Pain, Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior supra scapular nerve blockProcedure or surgery
nerve block for postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| Anterior suprasscapular nerve block | A single researcher will perform the nerve blocks of all participants. Receives: Procedure: anterior supra scapular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing.
Measured: postoperative 48 hours
Secondary outcomes (1)
diaphragm sparing nerve block
The volume of local anesthetic to be administered should be expected to have a common volume that is the most effective and protects the diaphragm. We envisioned that this should be defined as the minimum target-specific volume (MTsV).
Measured: 0 and 30 min after the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start7 Mar 2022
- Primary completion3 Jun 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Kaan Coşarcan, V.K.V. American Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241977
- Sponsor's protocol ID
- Cosarcan1
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2.
PubMed 24492959Fredrickson 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.
PubMed 20565394Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.
PubMed 25822923Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
PubMed 31283740Ilfeld BM, Morey TE, Wright TW, Chidgey LK, Enneking FK. Continuous interscalene brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 2003 Apr;96(4):1089-1095. doi: 10.1213/01.ANE.0000049824.51036.EF.
PubMed 12651666McNaught A, Shastri U, Carmichael N, Awad IT, Columb M, Cheung J, Holtby RM, McCartney CJ. Ultrasound reduces the minimum effective local anaesthetic volume compared with peripheral nerve stimulation for interscalene block. Br J Anaesth. 2011 Jan;106(1):124-30. doi: 10.1093/bja/aeq306. Epub 2010 Nov 8.
PubMed 21059701Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
PubMed 27941477
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINIMUM EFFECTIVE AND MAXIMUM DIAPHRAGM-SPARING VOLUME OF BUPIVACAİNE FOR ULTRASOUND GUIDED ANTERIOR SUPRASCAPULAR NERVE BLOCK
- ClinicalTrials.gov ID
- NCT05241977
- Acronym / sponsor ID
- Cosarcan1
- Conditions
- Shoulder Pain, Supraspinatus Tendinitis, Bankart Lesions
- Keywords
- regional anesthesia, shoulder arthroscopy, ortopaedic anesthesia, brachial plexus blocks, diaphragm sparing nerve blocks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 16 Feb 2022 (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.
Various local anesthetic volumes are used in the literature for anterior suprascapular nerve block (ASSB). There are different studies between 15 ml and 5 ml. Effective local anesthetic volume studies for ASSB have not yet been performed. Our study is aimed to investigate the minimum effective local anesthetic volume for ASSB.
Detailed description
Peripheral nerve blockade reduces pain scores and opioid consumption and increases patient satisfaction within the first 24 h after shoulder surgery. In the absence of neuraxial and peripheral nerve blocks, opioid consumption after shoulder surgery has been purported to rival the one recorded for thoracotomy. Interscalene brachial plexus blocks (ISBB) constitute the gold standard for analgesia after shoulder procedures. Compared with parenteral opioids, ISBB results in lower pain scores improved patient satisfaction [4]. ISBB is highly utilized in clinical practice as it provides anesthesia and analgesia to the shoulder and lateral aspects of the arm and the forearm, reducing opioid consumption and subsequent opioid-related adverse effects [5]. However, ISB is associated with numerous complications and adverse effects3 such as phrenic nerve palsy (100%), recurrent laryngeal nerve block (3 - 21%), stellate ganglion block (5 - 75%) (Horner's syndrome), spinal (0.4 - 4%) and epidural anesthesia (2.2%), and convulsions (0.2 - 3%) at standard volumes of 20 - 30 ml. Phrenic nerve block is associated with significant reductions in ventilatory function including a 21 - 34% decrease in forced vital capacity (FVC), 17 - 37% decrease in forced expiratory volume, and 15.4% decrease in peak expiratory flow rate. The most common adverse effect after ISB remains the occurrence of ipsilateral phrenic nerve block. Although well tolerated by healthy subjects, HDP becomes a prohibitive risk for patients with pulmonary pathology, who may be unable to withstand the 30% reduction in FVC. Viable diaphragm-sparing alternatives to ISB should achieve three separate and distinct goals: adequate surgical anesthesia (without general anesthesia), adequate postoperative analgesia, and low incidence of HDP. Alternative nerve blocks are performed in shoulder surgery to prevent HDP. Therefore, different approaches such as suprascapular nerve block, costoclavicular block, shoulder block, supraclavicular block, combined infraclavicular and suprascapular block, which are defined as diaphragm sparing blocks, are recommended.
Our study aimed to investigate the minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing. Our secondary aim is to reveal an important parameter in the diaphragm sparing nerve blocks. The volume of a local anesthetic to be administered should be expected to have a common volume that is the most effective and protects the diaphragm. We envisioned that this should be defined as the minimum target-specific volume (MTsV).
Adults (over 18 years of age) with the American Society of Anesthesiologists Physical Condition classification I to III who are scheduled to undergo unilateral ambulatory arthroscopic shoulder surgery under general anesthesia will be included in the study. Written informed consent will be obtained from all study subjects before participation in this study. Surgical procedures are planned to include shoulder arthroscopy, rotator cuff repair, acromioplasty, Bankart repair, and superior labrum anterior-posterior repair. Patients with a history of serious broncho-pulmonary disease, known phrenic nerve pathology, existing neurological deficits or neuropathy involving the brachial plexus on the surgical side, contraindications to nerve blocks (infection, bleeding diathesis, allergy to local anesthetics), or history will be excluded from the study. A full pre-operative evaluation will be performed with the necessary laboratories the day before the surgery, and written informed consent will be obtained.
The 0.5% initial injected volume of bupivacaine was 10 mL, providing a complete sensory block of anterior suprascapular nerve block based on our clinical experience. According to the Dixon and Massey [10] up-down method, the 0.5% bupivacaine volume used for a given patient was determined by the result of the previous block, as defined above as block success. Once effective ASSB is achieved, the volume of bupivacaine 0.5% to the next patient will be reduced by 1 mL. Conversely, in case of block failure, the volume of 0.5% bupivacaine will be increased by 1 mL in the next patient.
An independent observer will assess ipsilateral hemidiaphragmatic motion by real-time M-mode ultrasonography using a 1 to 5 MHz broadband phased array US probe (Philips CX50). Patients were examined in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as the acoustic window. The range of diaphragm movement from the resting expiratory position to deep inspiration (sigh test) and the range of diaphragm movement from the resting expiratory position when quickly inhaling through the nose (sniffing test) will be recorded. More than 75% hemidiaphragmatic movement reduction, no movement, or paradoxical movement will be considered complete paresis. Between 25% and 75%, hemidiaphragmatic movement decrease was considered partial paresis, and less than 25% hemidiaphragmatic movement decrease paresis was considered absent. The movement of the diaphragm will be measured in centimeters. The normal caudal movement was positive (+), paradoxical head movement was negative (-). Each test will be performed three times, and the values will be averaged. All measurements will be made before (beginning) and 30 minutes after the block.
Fifty minutes after the block performance, general anesthesia will be given using a standard protocol of intravenously administered propofol 2 mg/kg, Fentanyl 1 ug/kg, and rocuronium 0.6 mg/kg. Pain scores of the patients will be recorded for 48 hours postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior suprasscapular nerve block | – | Procedure: anterior supra scapular nerve blockA single researcher will perform the nerve blocks of all participants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age greater than 18 years with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery patients under general anesthesia.
Key inclusion criteria (1 listed)
- adults (age greater than 18 yr) with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery under general anesthesia
Key exclusion criteria (5 listed)
- dementia
- chronic opioid consumption
- chronic pain disease
- chronic obstructive pulmonary disease
- history of serious lung disease
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 |
|---|---|---|
| anterior supra scapular nerve blocknerve block for postoperative pain | Procedure or surgery | Anterior suprasscapular nerve block |
Primary outcome
postoperative analgesia
Time frame: postoperative 48 hours
minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing.
1 secondary outcome
diaphragm sparing nerve block
Time frame: 0 and 30 min after the nerve block
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 18 Jul 2022.
- Background: PubMed 24492959Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2.
- Background: PubMed 20565394Fredrickson 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.
- Background: PubMed 25822923Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.
- Background: PubMed 31283740Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
- Background: PubMed 12651666Ilfeld BM, Morey TE, Wright TW, Chidgey LK, Enneking FK. Continuous interscalene brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 2003 Apr;96(4):1089-1095. doi: 10.1213/01.ANE.0000049824.51036.EF.
- Background: PubMed 21059701McNaught A, Shastri U, Carmichael N, Awad IT, Columb M, Cheung J, Holtby RM, McCartney CJ. Ultrasound reduces the minimum effective local anaesthetic volume compared with peripheral nerve stimulation for interscalene block. Br J Anaesth. 2011 Jan;106(1):124-30. doi: 10.1093/bja/aeq306. Epub 2010 Nov 8.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 27941477Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Supraspinatus Tendinitis, run by V.K.V. American Hospital, Istanbul 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 1 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 18 Jul 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?
postoperative analgesia (time frame: postoperative 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 NCT05241977, which also lists 8 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 18 Jul 2022.