Phrenic Nerve ParalysisPhase 4NCT04756050
Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function
A Phase 4 study testing Bupivacaine HCl 0.5% Injectable Solution, Prilocaine HCl % 2 injectable solution and adrenaline amp 0.5mg in people with Phrenic Nerve Paralysis and Diaphragm Sellae Meningioma, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Brachial plexus blocks used for anesthesia in upper extremity operations can be performed with interscalene, axillary, supraclavicular and infraclavicular approaches. Plexus blockage can be performed under the guidance of needle nerve stimulation, artery palpation or ultrasonography (USG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phrenic Nerve Paralysis, Diaphragm Sellae Meningioma, Complications
- What is being tested?
- Bupivacaine HCl 0.5% Injectable Solution, Prilocaine HCl % 2 injectable solution and adrenaline amp 0.5mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2021to 2 Mar 2022
- Phase
- Phase 4
- 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
- Patients who are scheduled scheduled for hand, wrist, forearm, arm surgery
- Patients who has informed consent for study
- Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III
Who cannot join
- Patient's refusal to participate
- Patients under 18 years of age
- Patients with known local anesthetic allergy
- Patients with Body mass index> 35
- Patients diagnosed sepsis and bacteriemia,
- Skin infection at the injection site,
Show all 12Show fewer
- History of coagulopathy or anticoagulant therapy
- Patients with uncontrolled diabetes,
- Uncoordinated patients,
- Psychological and emotional lability,
- Patients with anatomical disorders at application points
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar, 35170
About this study
Official title: Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction
Brachial plexus blocks used for anesthesia in upper extremity operations can be performed with interscalene, axillary, supraclavicular and infraclavicular approaches.
Plexus blockage can be performed under the guidance of needle nerve stimulation, artery palpation or ultrasonography (USG).
Read more
Nowadays, the simultaneous use of USG during the block allows the protection of structures such as nerves, pleura and vessels, and allows practitioners to see the needle and the spread of local anesthetic during the injection.
Although supraclavicular block seems to be advantageous because the brachial plexus is more compact and superficial in this region, it has a disadvantage of being close to the pleura. (Increased risk of pneumothorax) With the use of USG, this risk has decreased and the supraclavicular block has become an alternative to infraclavicular block, which is widely used in upper extremity surgery.
Due to the compact structure of the brachial plexus trunk at the first rib level, the application of the block is easier and the block formation is faster due to the peripheral spread of the local anesthetic.
With the spread of local anesthetic to C3-C5 nerve roots in the brachial plexus, paralysis can be seen in the ipsilateral phrenic nerve up to 67%. Patients who will be operated on, especially in patients with respiratory distress, may experience respiratory distress due to the dysfunction of that side diaphragm muscle. With the help of ultrasound, the inspiratory and end-expiratory thickness of the diaphragm is measured with the Diaphragm Thickness Index (DTI), which is a new and effective method used as a mechanical ventilator weaning index in intensive care units. With this method, we can examine the effect of phrenic nerve block on diaphragm muscle due to local anesthesia in the acute period.
DTI is calculated as a percentage from the following formula:
(Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. By comparing 3 different approaches used in supraclavicular block, we aimed to investigate the most appropriate block approach in terms of effectiveness, speed, complication rate, effects on diaphragm and 6 months effects.
Read the detailed description
In this prospective randomized double-blind study, patients will be divided into 3 groups using a computer program.
Standard monitoring (ECG, pulse oximetry, noninvasive blood pressure) will be applied to the patients who will then be taken to the block application room . After the peripheral vascular access is established on the hand that will not be operated on, premedication will be provided with 2 mg iv midazolam.
The blocks will be performed by an experienced anesthesiologist with the USG guidance. Block evaluation and measurements will be made by a different experienced anesthesiologist. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. The local anesthetic mixture we routinely use in our clinic will be used. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) The ultrasound probe will be placed on the clavicle, the supraclavicular block will be applied in the coronal oblique plane using the in-plane technique.
3 different approaches of supraclavicular block will be compared. Approaches share the same probe position and needle entry point but differ in where the local anesthetic is given.
Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
Group 2: 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).
Group 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
The diaphragm thickening fraction and evaluations will be made by another experienced anesthesiologist, double-blindness will be achieved by being blind to the patient's group.
Effects of phrenic nerve block on diaphraghma muscle will be evaluated by diaphraghma thickining fraction.All patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed.The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus.
The diaphragm will be viewed as a structure with three distinct layers, including two parallel echoic lines (Diaphragmatic pleura and peritoneum) and a hypoechoic line between them (Diaphragm muscle) . The patient will be instructed to breathe up to total lung capacity (TLC) and then exhale to residual volume (RV).
Several diaphragm images will be taken, at least three at the point of maximum thickening in TLC and at least three at minimum thickness in RV.
On each B-mode image, diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then DTI will be calculated as a percentage from the following formula:
(Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration.
With this formula, we can determine the involvement of phrenic nerve by looking at the rate of diaphragm thickening before and after supraclavicular block in different groups.
As a first line rescue anesthesia, patients will receive sedoanalgesia with remifentanil infusion. Laryngeal mask and general anesthesia will be commenced if needed. The postoperative analgesic regimen will routinely contain 1000 mg IV acetaminophen (3x1) and, if necessary, 1 mg opioid (Tramadol) per kg will be given.
- Conditions
- Phrenic Nerve Paralysis, Diaphragm Sellae Meningioma, Complications, Respiratory Complication, Nerve Block, Brachial Plexus Block
- Being tested
- Bupivacaine HCl 0.5% Injectable Solution, Prilocaine HCl % 2 injectable solution, adrenaline amp 0.5mg, Ultrasound Guided Supraclavicular Block Corner pocket approach, Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach
- Keywords
- Brachial Plexus Block, Phrenic Nerve Paralysis, Respiratory Complication, Complications, nerve block, Diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCl 0.5% Injectable SolutionDrug
Also called buvicaine %0.5,
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
Prilocaine HCl % 2 injectable solutionDrug
Also called priloc %2
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
adrenaline amp 0.5mgDrug
Also called adrenalin codex 0.5mg/1ml injectable solution
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
Ultrasound Guided Supraclavicular Block Corner pocket approachProcedure or surgery
The blocks will be performed by an experienced anesthesiologist with a USG guidance. Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approachProcedure or surgery
The blocks will be performed by an experienced anesthesiologist with a USG guidance .10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).
Ultrasound Guided Supraclavicular Block multi approachProcedure or surgery
The blocks will be performed by an experienced anesthesiologist with a USG guidance Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
diagraphma muscle evaluation with ultrasoundProcedure or surgery
All patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed.
The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus.
| Study group | Role | What they receive |
|---|---|---|
| corner pocket | Experimental | The block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image. Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket approach; Procedure: diagraphma muscle evaluation with ultrasound |
| corner+intracluster | Experimental | The block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection). Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach; Procedure: diagraphma muscle evaluation with ultrasound |
| multi | Experimental | The block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image. Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block multi approach; Procedure: diagraphma muscle evaluation with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction
Several diaphragm images will be taken, at least three at the point of maximum thickening in TLC and at least three at minimum thickness in RV. On each B-mode image, diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then DTI will be calculated as a percentage from the formula: (Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. All patients will be evaluated with USG in a head-up position facing the side to be operated 30 minutes after the block is performed.
Measured: Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed.
Secondary outcomes (13)
The sensory block level
Sensory block level; The level of block that will occur in the sensory areas of axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia and cutaneous antebraki medialis nerves will be evaluated by performing a pinprick test and its level will be recorded (0 = Painful, no block; 1 = Partial block-analgesia, only feeling of touch; 2 = Complete block, no pain).
Measured: Following the block operation, the sensory block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes
The motor block level
It will be evaluated with the Modified Bromage scale:
0 = No blocks, he can lift his arm,
1= Motor power is low but the arm is movable, 2 = The arm is immobile but the fingers are movable, 3 = Complete block, no movement in hand or arm
Measured: Following the block operation, the motor block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes
Block success
It will be defined as the presence of the pinprick test in the musculacutaneous, radial, ulnar, median, cutaneous antebraki nerves with no pain or only feeling of touch. If any of these nerves are not blocked, it will be considered a failed block.
Measured: At the 30th minute of LA application,
Postoperative analgesia time
Numeric rating scale; patient values pain between 0 and 10; 0 = No pain-10 = Intractable pain
Measured: The hour when NRS> 1 in the first 24 hours will be recorded.
Pain Score Follow-up
Numeric rating scale; patient values pain between 0 and 10; 0 = No pain-10 = Intractable pain
Measured: 2nd, 6th, 12th and 24th hours
Block return time
Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection to the moment the patient's upper limb regains muscle strength) will be recorded as the time to return the block.
Measured: The return time of sensory and motor block will be recorded within the first 24 hours.
Block application time
It will be defined as the time from the moment the needle passes through the skin until the local anesthetic is given and the needle is withdraw.
Measured: intraoperative (during block application)
Block onset time
It will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves from the local anesthetic injection.
Measured: baseline (before surgery)
Patient and surgeon satisfaction
Patient and surgeon satisfaction will be evaluated as: 1 = Complete dissatisfaction, 2 = Moderate satisfaction, 3 = Full satisfaction after the procedure.
Measured: immediately after the surgery
Undesirable side effects:
Recorded when there is vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and Horner Syndrome.
Measured: Patients will be observed for 24 hours,
The first opioid requirement hour
The first hour of opioid requirement of the patients will be recorded.(When NRS> 3) Opioids(Tramadol) will be administered to patients in case demanded.
Measured: If pain occurs within the first 24 hours from the time the block transaction ends.
24-hour total opioid consumption
It will be recorded how much opioid he needs to use for 24 hours.Opioids(Tramadol) will be administered to patients in case demanded.
Measured: It will be defined as 24 hours from the time the block transaction ends.
Chronic pain questionnaire
After 6 months, patients will be called and questioned by phone.
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start16 Feb 2021
- Primary completion15 Aug 2021
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Phrenic Nerve ParalysisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups involved. 3 different approaches of supraclavicular block will be compared. Approaches share the same probe position and needle entry point but differ in where the local anesthetic is given. Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image. Group 2: 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection). Group 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağrı Yeşilnacar, Bozyaka Training and Research Hospital
- Investigators
- Çağrı Yeşilnacar, MD, Study chair, Izmir Bozyaka Training and Research HospitalZeki T Tekgül, Assoc Prof, Study chair, Izmir Bozyaka Training and Research HospitalAYSUN A KAR, MD, Study chair, Izmir Bozyaka Training and Research HospitalTAŞKIN ALTAY, Assoc Prof, Study chair, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756050
- Sponsor's protocol ID
- cagritez
- Status last verified
- Jun 2023
- First submitted
- 8 Feb 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
PubMed 24949192Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.
PubMed 25650633Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.
PubMed 19916254
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction
- ClinicalTrials.gov ID
- NCT04756050
- Acronym / sponsor ID
- cagritez
- Conditions
- Phrenic Nerve Paralysis, Diaphragm Sellae Meningioma, Complications, Respiratory Complication, Nerve Block, Brachial Plexus Block
- Keywords
- Brachial Plexus Block, Phrenic Nerve Paralysis, Respiratory Complication, Complications, nerve block, Diaphragm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 16 Feb 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.
Brachial plexus blocks used for anesthesia in upper extremity operations can be performed with interscalene, axillary, supraclavicular and infraclavicular approaches.
Plexus blockage can be performed under the guidance of needle nerve stimulation, artery palpation or ultrasonography (USG).
Nowadays, the simultaneous use of USG during the block allows the protection of structures such as nerves, pleura and vessels, and allows practitioners to see the needle and the spread of local anesthetic during the injection.
Although supraclavicular block seems to be advantageous because the brachial plexus is more compact and superficial in this region, it has a disadvantage of being close to the pleura. (Increased risk of pneumothorax) With the use of USG, this risk has decreased and the supraclavicular block has become an alternative to infraclavicular block, which is widely used in upper extremity surgery.
Due to the compact structure of the brachial plexus trunk at the first rib level, the application of the block is easier and the block formation is faster due to the peripheral spread of the local anesthetic.
With the spread of local anesthetic to C3-C5 nerve roots in the brachial plexus, paralysis can be seen in the ipsilateral phrenic nerve up to 67%. Patients who will be operated on, especially in patients with respiratory distress, may experience respiratory distress due to the dysfunction of that side diaphragm muscle. With the help of ultrasound, the inspiratory and end-expiratory thickness of the diaphragm is measured with the Diaphragm Thickness Index (DTI), which is a new and effective method used as a mechanical ventilator weaning index in intensive care units. With this method, we can examine the effect of phrenic nerve block on diaphragm muscle due to local anesthesia in the acute period.
DTI is calculated as a percentage from the following formula:
(Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. By comparing 3 different approaches used in supraclavicular block, we aimed to investigate the most appropriate block approach in terms of effectiveness, speed, complication rate, effects on diaphragm and 6 months effects.
Detailed description
In this prospective randomized double-blind study, patients will be divided into 3 groups using a computer program.
Standard monitoring (ECG, pulse oximetry, noninvasive blood pressure) will be applied to the patients who will then be taken to the block application room . After the peripheral vascular access is established on the hand that will not be operated on, premedication will be provided with 2 mg iv midazolam.
The blocks will be performed by an experienced anesthesiologist with the USG guidance. Block evaluation and measurements will be made by a different experienced anesthesiologist. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. The local anesthetic mixture we routinely use in our clinic will be used. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) The ultrasound probe will be placed on the clavicle, the supraclavicular block will be applied in the coronal oblique plane using the in-plane technique.
3 different approaches of supraclavicular block will be compared. Approaches share the same probe position and needle entry point but differ in where the local anesthetic is given.
Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
Group 2: 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).
Group 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
The diaphragm thickening fraction and evaluations will be made by another experienced anesthesiologist, double-blindness will be achieved by being blind to the patient's group.
Effects of phrenic nerve block on diaphraghma muscle will be evaluated by diaphraghma thickining fraction.All patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed.The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus.
The diaphragm will be viewed as a structure with three distinct layers, including two parallel echoic lines (Diaphragmatic pleura and peritoneum) and a hypoechoic line between them (Diaphragm muscle) . The patient will be instructed to breathe up to total lung capacity (TLC) and then exhale to residual volume (RV).
Several diaphragm images will be taken, at least three at the point of maximum thickening in TLC and at least three at minimum thickness in RV.
On each B-mode image, diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then DTI will be calculated as a percentage from the following formula:
(Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration.
With this formula, we can determine the involvement of phrenic nerve by looking at the rate of diaphragm thickening before and after supraclavicular block in different groups.
As a first line rescue anesthesia, patients will receive sedoanalgesia with remifentanil infusion. Laryngeal mask and general anesthesia will be commenced if needed. The postoperative analgesic regimen will routinely contain 1000 mg IV acetaminophen (3x1) and, if necessary, 1 mg opioid (Tramadol) per kg will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups involved. 3 different approaches of supraclavicular block will be compared. Approaches share the same probe position and needle entry point but differ in where the local anesthetic is given. Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image. Group 2: 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection). Group 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
| Arm | Type | Receives |
|---|---|---|
| corner pocket | Experimental | Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Prilocaine HCl % 2 injectable solution, Drug: adrenaline amp 0.5mg, Procedure: Ultrasound Guided Supraclavicular Block Corner pocket approach, Procedure: diagraphma muscle evaluation with ultrasoundThe block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image. |
| corner+intracluster | Experimental | Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Prilocaine HCl % 2 injectable solution, Drug: adrenaline amp 0.5mg, Procedure: Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach, Procedure: diagraphma muscle evaluation with ultrasoundThe block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection). |
| multi | Experimental | Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Prilocaine HCl % 2 injectable solution, Drug: adrenaline amp 0.5mg, Procedure: Ultrasound Guided Supraclavicular Block multi approach, Procedure: diagraphma muscle evaluation with ultrasoundThe block will be performed by an experienced anesthesiologist in block applications under USG guidance. After the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the block . Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are scheduled scheduled for hand, wrist, forearm, arm surgery
- Patients who has informed consent for study
- Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III
Key exclusion criteria (12 listed)
- Patient's refusal to participate
- Patients under 18 years of age
- Patients with known local anesthetic allergy
- Patients with Body mass index> 35
- Patients diagnosed sepsis and bacteriemia,
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 HCl 0.5% Injectable SolutionAlso: buvicaine %0.5,20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) | Drug | corner pocket, corner+intracluster, multi |
| Prilocaine HCl % 2 injectable solutionAlso: priloc %220 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) | Drug | corner pocket, corner+intracluster, multi |
| adrenaline amp 0.5mgAlso: adrenalin codex 0.5mg/1ml injectable solution20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml) | Drug | corner pocket, corner+intracluster, multi |
| Ultrasound Guided Supraclavicular Block Corner pocket approachThe blocks will be performed by an experienced anesthesiologist with a USG guidance. Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image. | Procedure or surgery | corner pocket |
| Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approachThe blocks will be performed by an experienced anesthesiologist with a USG guidance .10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection). | Procedure or surgery | corner+intracluster |
| Ultrasound Guided Supraclavicular Block multi approachThe blocks will be performed by an experienced anesthesiologist with a USG guidance Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image. | Procedure or surgery | multi |
| diagraphma muscle evaluation with ultrasoundAll patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed. The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus. | Procedure or surgery | corner pocket, corner+intracluster, multi |
Primary outcome
Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction
Time frame: Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed.
Several diaphragm images will be taken, at least three at the point of maximum thickening in TLC and at least three at minimum thickness in RV. On each B-mode image, diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then DTI will be calculated as a percentage from the formula: (Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. All patients will be evaluated with USG in a head-up position facing the side to be operated 30 minutes after the block is performed.
13 secondary outcomes
The sensory block level
Time frame: Following the block operation, the sensory block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes
The motor block level
Time frame: Following the block operation, the motor block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes
Block success
Time frame: At the 30th minute of LA application,
Postoperative analgesia time
Time frame: The hour when NRS> 1 in the first 24 hours will be recorded.
Pain Score Follow-up
Time frame: 2nd, 6th, 12th and 24th hours
Block return time
Time frame: The return time of sensory and motor block will be recorded within the first 24 hours.
Block application time
Time frame: intraoperative (during block application)
Block onset time
Time frame: baseline (before surgery)
Patient and surgeon satisfaction
Time frame: immediately after the surgery
Undesirable side effects:
Time frame: Patients will be observed for 24 hours,
The first opioid requirement hour
Time frame: If pain occurs within the first 24 hours from the time the block transaction ends.
24-hour total opioid consumption
Time frame: It will be defined as 24 hours from the time the block transaction ends.
Chronic pain questionnaire
Time frame: 6 months after operation
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 13 Jun 2023.
- Background: PubMed 24949192Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
- Background: PubMed 25650633Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.
- Background: PubMed 19916254Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.
- Individual participant dataSharing planned: No
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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.
Çağrı Yeşilnacar, MD study chair
Izmir Bozyaka Training and Research Hospital
Zeki T Tekgül, Assoc Prof study chair
Izmir Bozyaka Training and Research Hospital
AYSUN A KAR, MD study chair
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine HCl 0.5% Injectable Solution, Prilocaine HCl % 2 injectable solution and adrenaline amp 0.5mg in people with Phrenic Nerve Paralysis and Diaphragm Sellae Meningioma, run by Bozyaka Training and Research Hospital 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 3 inclusion and 12 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 13 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction (time frame: Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed.). 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 NCT04756050, which also lists 3 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 13 Jun 2023.