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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Nevert adel

    Al Mansurah

Other trials in Egypt

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 groups in NCT04050891
Study groupRoleWhat they receive
group GA (general anesthesia)No interventionAfter 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 comparatorreceived 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.

  1. Pain assessment by numerical rating scale

    was explained to all candidates (zero = no pain and 10 = the worst pain)

    Measured: 24 hours after surgery

  2. 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

  3. 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

  4. graft potency

    by doppler

    Measured: up to one month after surgery

Secondary outcomes (3)
  1. 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

  2. time to first intravenous analgesic requirement

    1ug/kg fentanyl was given if NRS ≥4

    Measured: 24 hours after surgery

  3. 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.

  1. First posted8 Aug 2019
  2. Study start1 Jun 2018
  3. Primary completion1 Jul 2019
  4. Study completion10 Jul 2019

Resources

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)
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

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.

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