AnesthesiaNCT04050891
Comparative Study of Ultrasound Guided Combined Interscalene and Supraclavicular Brachial Plexus Block Versus General Anesthesia for Brachioaxillary Surgery in Renal Failure Patient
A study testing combined supraclavicular and interscalene block in people with Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- combined supraclavicular and interscalene block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 10 Jul 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- sixty patients of chronic renal failure,
- ASA III,
- aged from 20 to 60 years old
- of either sex
- planned for brachioaxillary graft interposition vascular surgery were enrolled.
Who cannot join
- Patients refusal,
- have allergy to local anesthetic,
- neurological, neuromuscular, psychiatric disorders,
- uncompensated hepatic, respiratory or cardiac disease,
- uncontrolled seizures,
- coagulation disorders,
- infection at the block injection site,
- body mass index more than 30
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia.
Read the detailed description
This randomized open blinded end-point pilot study was implemented at Mansoura University Hospitals. After acceptance of Institutional Research Board (No: MS/17.08.26), sixty patients of chronic renal failure, The American Society of Anesthesiologists (ASA) III, aged from 20 to 60 years old of either sex and planned for brachioaxillary graft interposition vascular surgery were enrolled.
Patients refusal, have allergy to local anesthetic, neurological, neuromuscular, psychiatric disorders, uncompensated hepatic, respiratory or cardiac disease, uncontrolled seizures, coagulation disorders, infection at the block injection site, body mass index more than 30 were excluded.
Written informed consents were obtained. Patients were classified using closed envelop method into two groups; group (GA) received general anesthesia; group (RA) received combined supraclavicular and interscalene block, each group were carried on 30 patients.
All patients were subjected to the preoperative assessment including history taking, clinical examination and assessment of ASA score. All patients subjected to dialysis session one day before the surgery. Basal laboratory investigation as complete blood count, coagulation profile (prothrombin time, international normalized ratio and activated partial thromboplastin time), arterial blood gases, Electrocardiography and echocardiography were done after dialysis.
After an overnight fasting, patients admitted to preanesthetic room where an intravenous (IV) cannula was inserted in the contralateral upper limb. Standard monitoring was applied to the patient include heart rate (HR), noninvasive blood pressure (NIBP), peripheral oxygen saturation (SpO2).
Numerical rating scale (NRS) was explained to all candidates (zero = no pain and 10 = the worst pain). Patients were lightly sedated by fentanyl 0.5 μg /kg IV to maintain verbal contact.
Group (GA):
After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values.
At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine. Patients were discharged from post anesthesia care unit according to modified Aldrete recovery score ≥ 9 . Side effects or complications were recorded.
Group (RA):
Equipment Sterile gloves, Sterile gauze, Alcohol and betadine solution for sterilization, 22 gauge 90mm stimulating needle, 3 ml syringe filled with 3ml 2% lidocaine for local infiltration at the site of needle entry, 50 ml syringe filled with local anesthetic prepared for injection, Ultrasound device (philips, clearvue 350,USA) and high frequency (4-12MHZ) Linear probe was used in this study, its depth setting was 2-4cm .
The mixture of anesthetic solution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is divided into 25ml for supraclavicular block and 15ml for interscalene block .
Patient position The patient was placed in supine position with the head turned 45 degrees to the contralateral side.
Supraclavicular block :
Land marks Subclavian artery pulsation which appears as a pulsatile hypoechoic circle, The nerves appear as multiple hypoechoic circles, the most common appearance is a grape like clusters of 4-6 circles likely resembling the divisions or as vertical line of 3 circles likely representing the trunks of the brachial plexus. First rib which appears as hyperechoic linear line. The pleura can also be visualized as hyperechoic line.
After skin preparation and local anesthetic infiltration of the skin, supraclavicular fossa was scanned to locate the landmarks. If there was difficulty in finding the subclavian artery, the transducer was slide medially to identify the distal carotid artery firstly , then moved laterally to image the subclavian artery which rested on the first rib, the pulsation was confirmed by doppler colour. The nerves will appear just lateral and superior to the artery.
An in plane approach, a 22 gauge needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferior and the plexus superior then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery.
Interscalene block Land marks The linear probe was placed at the level of the cricoids cartilage. Carotid artery, anterior scalene muscle, middle scalene muscle, sternomastoid muscle, internal jugular vein and nerves in the inter-scalene groove appear hypoechoic distinctly round or oval were seen.
After local anesthetic infiltration of the skin, a 22 gauge needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block .
The sensory block will be assessed by pinprick test and recorded in two stages: 0= normal sensation; 1= no pain. Onset of sensory block is the time between the end of injection and total abolition of pinprick sensation. Sensory loss was assessed every 3 minutes until 30 minutes after block. The block was defined as complete when loss of sensation is observed in all tested areas .
Motor loss was assessed every 3 minutes until 30 minutes after injection. The block was defined as complete when loss of movement is observed in all tested areas. Motor block was evaluated in the following stages: 0= no weakness; 1= paresis; 2= paralysis. Onset of motor block is the time gaped between the end of injection to complete motor block .
The onset of surgical anesthesia is defined as the time of loss of pinprick sensation at the skin dermatomes involved in the surgical field and inability to do motor functions specific to each nerve.
After operation, patients transferred to the recovery room and monitored. Heart rate, mean arterial blood pressure and SpO2 were recorded for 24 hours.
- Conditions
- Anesthesia
- Being tested
- combined supraclavicular and interscalene block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined supraclavicular and interscalene blockDevice
Supraclavicular block An in plane approach, a 22G needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferiorly and the plexus superiorly then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery.
Interscalene block After local anesthetic infiltration of the skin, a 22G needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block.
| Study group | Role | What they receive |
|---|---|---|
| group GA (general anesthesia) | No intervention | After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values. At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine. |
| group RA (regional anesthesia) | Active comparator | received combined supraclavicular and interscalene block.The mixture of anesthetic suolution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is devided into 25ml for suraclavicular block and 15ml for intersalene block Receives: Device: combined supraclavicular and interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment by numerical rating scale
was explained to all candidates (zero = no pain and 10 = the worst pain)
Measured: 24 hours after surgery
satisfaction of the surgeon to the combined block supraclavicular and interscalene during operation
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
Measured: 3 hours
satisfaction of the patients to the combined block
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
Measured: 3 hours
graft potency
by doppler
Measured: up to one month after surgery
Secondary outcomes (3)
The onset and duration of sensory and motor block
recorded after performing regional block for group (RA) over the whole upper limb.
Measured: 30 minutes after block
time to first intravenous analgesic requirement
1ug/kg fentanyl was given if NRS ≥4
Measured: 24 hours after surgery
Number of times of needed analgesia
Number of times patients need analgesia
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jun 2018
- Primary completion1 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050891
- Sponsor's protocol ID
- MS/17.08.26
- Status last verified
- Sep 2020
- First submitted
- 2 Aug 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Ultrasound Guided Combined Interscalene and Supraclavicular Brachial Plexus Block Versus General Anesthesia for Brachioaxillary Surgery in Renal Failure Patient
- ClinicalTrials.gov ID
- NCT04050891
- Acronym / sponsor ID
- MS/17.08.26
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 8 Aug 2019 (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 aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia.
Detailed description
This randomized open blinded end-point pilot study was implemented at Mansoura University Hospitals. After acceptance of Institutional Research Board (No: MS/17.08.26), sixty patients of chronic renal failure, The American Society of Anesthesiologists (ASA) III, aged from 20 to 60 years old of either sex and planned for brachioaxillary graft interposition vascular surgery were enrolled.
Patients refusal, have allergy to local anesthetic, neurological, neuromuscular, psychiatric disorders, uncompensated hepatic, respiratory or cardiac disease, uncontrolled seizures, coagulation disorders, infection at the block injection site, body mass index more than 30 were excluded.
Written informed consents were obtained. Patients were classified using closed envelop method into two groups; group (GA) received general anesthesia; group (RA) received combined supraclavicular and interscalene block, each group were carried on 30 patients.
All patients were subjected to the preoperative assessment including history taking, clinical examination and assessment of ASA score. All patients subjected to dialysis session one day before the surgery. Basal laboratory investigation as complete blood count, coagulation profile (prothrombin time, international normalized ratio and activated partial thromboplastin time), arterial blood gases, Electrocardiography and echocardiography were done after dialysis.
After an overnight fasting, patients admitted to preanesthetic room where an intravenous (IV) cannula was inserted in the contralateral upper limb. Standard monitoring was applied to the patient include heart rate (HR), noninvasive blood pressure (NIBP), peripheral oxygen saturation (SpO2).
Numerical rating scale (NRS) was explained to all candidates (zero = no pain and 10 = the worst pain). Patients were lightly sedated by fentanyl 0.5 μg /kg IV to maintain verbal contact.
Group (GA):
After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values.
At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine. Patients were discharged from post anesthesia care unit according to modified Aldrete recovery score ≥ 9 . Side effects or complications were recorded.
Group (RA):
Equipment Sterile gloves, Sterile gauze, Alcohol and betadine solution for sterilization, 22 gauge 90mm stimulating needle, 3 ml syringe filled with 3ml 2% lidocaine for local infiltration at the site of needle entry, 50 ml syringe filled with local anesthetic prepared for injection, Ultrasound device (philips, clearvue 350,USA) and high frequency (4-12MHZ) Linear probe was used in this study, its depth setting was 2-4cm .
The mixture of anesthetic solution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is divided into 25ml for supraclavicular block and 15ml for interscalene block .
Patient position The patient was placed in supine position with the head turned 45 degrees to the contralateral side.
Supraclavicular block :
Land marks Subclavian artery pulsation which appears as a pulsatile hypoechoic circle, The nerves appear as multiple hypoechoic circles, the most common appearance is a grape like clusters of 4-6 circles likely resembling the divisions or as vertical line of 3 circles likely representing the trunks of the brachial plexus. First rib which appears as hyperechoic linear line. The pleura can also be visualized as hyperechoic line.
After skin preparation and local anesthetic infiltration of the skin, supraclavicular fossa was scanned to locate the landmarks. If there was difficulty in finding the subclavian artery, the transducer was slide medially to identify the distal carotid artery firstly , then moved laterally to image the subclavian artery which rested on the first rib, the pulsation was confirmed by doppler colour. The nerves will appear just lateral and superior to the artery.
An in plane approach, a 22 gauge needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferior and the plexus superior then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery.
Interscalene block Land marks The linear probe was placed at the level of the cricoids cartilage. Carotid artery, anterior scalene muscle, middle scalene muscle, sternomastoid muscle, internal jugular vein and nerves in the inter-scalene groove appear hypoechoic distinctly round or oval were seen.
After local anesthetic infiltration of the skin, a 22 gauge needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block .
The sensory block will be assessed by pinprick test and recorded in two stages: 0= normal sensation; 1= no pain. Onset of sensory block is the time between the end of injection and total abolition of pinprick sensation. Sensory loss was assessed every 3 minutes until 30 minutes after block. The block was defined as complete when loss of sensation is observed in all tested areas .
Motor loss was assessed every 3 minutes until 30 minutes after injection. The block was defined as complete when loss of movement is observed in all tested areas. Motor block was evaluated in the following stages: 0= no weakness; 1= paresis; 2= paralysis. Onset of motor block is the time gaped between the end of injection to complete motor block .
The onset of surgical anesthesia is defined as the time of loss of pinprick sensation at the skin dermatomes involved in the surgical field and inability to do motor functions specific to each nerve.
After operation, patients transferred to the recovery room and monitored. Heart rate, mean arterial blood pressure and SpO2 were recorded for 24 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group GA (general anesthesia) | No intervention | –After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values. At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine. |
| group RA (regional anesthesia) | Active comparator | Device: combined supraclavicular and interscalene blockreceived combined supraclavicular and interscalene block.The mixture of anesthetic suolution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is devided into 25ml for suraclavicular block and 15ml for intersalene block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- sixty patients of chronic renal failure,
- ASA III,
- aged from 20 to 60 years old
- of either sex
- planned for brachioaxillary graft interposition vascular surgery were enrolled.
Key exclusion criteria (8 listed)
- Patients refusal,
- have allergy to local anesthetic,
- neurological, neuromuscular, psychiatric disorders,
- uncompensated hepatic, respiratory or cardiac disease,
- uncontrolled seizures,
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 |
|---|---|---|
| combined supraclavicular and interscalene blockSupraclavicular block An in plane approach, a 22G needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferiorly and the plexus superiorly then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery. Interscalene block After local anesthetic infiltration of the skin, a 22G needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block. | Device | group RA (regional anesthesia) |
Primary outcome
Pain assessment by numerical rating scale
Time frame: 24 hours after surgery
was explained to all candidates (zero = no pain and 10 = the worst pain)
satisfaction of the surgeon to the combined block supraclavicular and interscalene during operation
Time frame: 3 hours
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
satisfaction of the patients to the combined block
Time frame: 3 hours
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
graft potency
Time frame: up to one month after surgery
by doppler
3 secondary outcomes
The onset and duration of sensory and motor block
Time frame: 30 minutes after block
time to first intravenous analgesic requirement
Time frame: 24 hours after surgery
Number of times of needed analgesia
Time frame: 24 hours after surgery
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 14 Sep 2020.
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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?
A study testing combined supraclavicular and interscalene block in people with Anesthesia, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 8 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 14 Sep 2020. 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 Egypt. 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?
Pain assessment by numerical rating scale (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.