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AnalgesiaNCT05381389

Onset and Recovery of Ultrasound Guided Out-of-plane Versus In-plane Interscalene Block in Arthroscopic Shoulder Surgery

A study testing Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block in people with Analgesia, run by Ain Shams 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 was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the… Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Analgesia
What is being tested?
Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Dec 2018to 1 Jun 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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • ASA physical status I - II
  • scheduled to undergo arthroscopic shoulder surgery in the lateral position

Who cannot join

  • body mass index ≥ 35 kg/m2 body surface area
  • anticipated difficult airway
  • infection at the injection site
  • known LA allergy,
  • contralateral phrenic nerve dysfunction
  • history of cardiac disease
Show all 11Show fewer
  • history of hepatic disease
  • history of renal disease
  • coagulopathy
  • chronic obstructive pulmonary disease
  • neuropathy involving the brachial plexus.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain-Shams University

    Cairo

Other trials in Egypt

About this study

The aim of this study was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the duration of analgesia for arthroscopic shoulder surgery. A total of 60 patients of American Society of Anesthesiologists (ASA) physical status I-II were randomly divided to receive either the in-plane approach (Group I), or the out-of-plane approach (Group O).

Read the detailed description

60 patients of ASA physical status I - II, greater than or equal to 30 years old and smaller than or equal to 60 years old, scheduled to undergo arthroscopic shoulder surgery in the lateral position; under ultrasound -guided interscalene brachial plexus block (ISPB) in this randomized study at Ain-Shams University Hospitals. On arriving to the operating theater, patients had an 18G intravenous cannula inserted in the non-operative upper limb side. All patients received; 0.05 mg/kg IV midazolam hydrochloride and 30 mg pethidine. Intraoperative basic monitors were applied using 5-leads ECG, pulse oximetry, non-invasive blood pressure (NIBP) and capnography (sample tube inserted under the O2 mask).A simple O2 mask at a flow of 6L/min was applied. Infusion of Ringer's solution was then started at a rate of 5mL/kg/h throughout the surgery. Patients were placed in the supine position with their heads rotated towards the non-operative side. Iodine solution was used as an antiseptic on the operative neck side and then the patient head, neck and chest were draped. Local infiltration of the skin at the point of needle insertion was carried out with 2 ml lidocaine hydrochloride 1%, then a sterile 50-mm 22-G insulated needle was used for performance of the block.The ultrasound with a high frequency linear transducer was used, with the depth setting of 2-4 cm. Distal to proximal (Trace back) approach was used; the supraclavicular fossa was scanned first to identify the subclavian artery as it passes over the first rib; by placing the probe against the clavicle and scanning in a caudate direction. The brachial plexus was easily identified as bunch of grapes supero-lateral to the artery. The plexus was followed medially and cephalad along its course by keeping the nerves in the center of the screen, to identify the brachial plexus roots between the anterior and the middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle.

Patients were then divided into 2 equal groups of 30 patients each:

Group I: An in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root.

Group O: An out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen.

After completion of the LA administration, the time was recorded as a baseline for the time interval. The assistant who recorded the data was blind to the patient groups. The sensory block was assessed by a pin-prick test using a 3-point scale. The motor block was assessed according to the shoulder, arm and fingers movement using a 3-point scale. Postoperative pain was measured at rest using the VAS score

Conditions
Analgesia
Being tested
Bupivacaine Hydrochloride in-plane approach for the interscalene block, Bupivacaine Hydrochloride out of-plane approach for the interscalene block
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine Hydrochloride in-plane approach for the interscalene blockDrug

    20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an in-plane approach to the brachial plexues

  • Bupivacaine Hydrochloride out of-plane approach for the interscalene blockDrug

    20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an out of-plane approach to the brachial plexues

Study groups in NCT05381389
Study groupRoleWhat they receive
Group In-plane approach:Active comparatorAn in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root.
Receives: Drug: Bupivacaine Hydrochloride in-plane approach for the interscalene block
Group Out-of-plane approachActive comparatorAn out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen.
Receives: Drug: Bupivacaine Hydrochloride out of-plane approach for the interscalene block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The onset of sensory block (time to C5 block)

    defined as the period between the completion of the LA administration and the loss of sensation to pin prick in C5 dermatome performed every 1 minute

    Measured: 30 minutes

Secondary outcomes (7)
  1. The procedure time

    time from the skin infiltration by the lidocaine till removal of the stimulating needle from the skin

    Measured: 20 minutes

  2. Progression of sensory block

    performed by pin prick every 5 minutes in C6, C7, C8 and T1 dermatomes

    Measured: over the first 20 minutes of LA injection

  3. The onset of motor block

    the period between the completion of LA administration till lack of movement of the shoulder, arm and fingers muscles assessed every 1 minute.

    Measured: 30 minutes

  4. The progression of motor block

    in the shoulder, arm and fingers muscles assessed every 5 minutes

    Measured: over the first 20 minutes of LA injection

  5. The duration of motor block

    the period between the onset of motor block till complete recovery of motor function

    Measured: 24 hours

  6. Postoperative pain score

    Intensity of pain was monitored at rest

    Measured: 24 hours

  7. The duration of analgesia

    the time interval between the onset of sensory block until the first call for analgesia

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start1 Dec 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381389
Sponsor's protocol ID
FMASU R59/2018
Status last verified
May 2022
First submitted
12 May 2022
Last updated
19 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block in people with Analgesia, run by Ain Shams 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 2 inclusion and 11 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 19 May 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 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?

The onset of sensory block (time to C5 block) (time frame: 30 minutes). 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 19 May 2022.

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