AzTrials
AzTrials

Best Regional Nerve Block for Creation of Surgical Brachiobasilic FistulaPhase 3NCT04311255

Comparing the Efficacy and Safety of Ultrasound Guided Supraclavicular Block Combined With Either Intercostobrachialor Pec 11for Creation of Surgical Brachio-basilic Fistula in Chronic Renal Failure Patients on Hemodialysis

A Phase 3 study testing regional anesthesia for the upper limb in people with Best Regional Nerve Block for Creation of Surgical Brachiobasilic Fistula, 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

In our study we are trying to reach to the more efficient us guided peripheral nerve block either intercosto-brachial or PPEC 11 that can be combined with us guided supraclavicular block to effectively anesthetise the surgical site for creation of brachio-basilic fistula as regarding onset of surgical anesthesia… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
regional anesthesia for the upper limb
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteEgypt
Study dates
13 Apr 2019to 3 May 2020
Phase
Phase 3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologists Grade III, age 25-75 years who are scheduled for brachio-basilic AVF.

Who cannot join

  • Patients will be excluded if they have infection at the injection site, allergy to local anesthetics, chronic use of opioids, a history of neurological neuromuscular, or severe hepatic or cardiopulmonary disease, a contraindication to regional anesthesia or patient /guardian refusal.
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams Unuversity Hospitals

    Cairo, 11455

Other trials in Egypt

About this study

Official title: Comparing the Efficacy and Safety of Ultrasound Guided Supraclavicular Block Combined With Either Intercosto-brachial Nerve Block or pec11block for Creation of Surgical Brachio-basilic Fistula in Chronic Renal Failure Patients on Hemodialysis

In our study we are trying to reach to the more efficient us guided peripheral nerve block either intercosto-brachial or PPEC 11 that can be combined with us guided supraclavicular block to effectively anesthetise the surgical site for creation of brachio-basilic fistula as regarding onset of surgical anesthesia, adequacy of intra-operative anesthesia, the need for surgical wound infiltration, duration of postoperative analgesia and the failure rate of the fistulae.

Read the detailed description
  • Type of Study: Randomized Prospective trail
  • Study Setting: Ain Shams University Hospitals, Cairo, Egypt
  • Study Period: 6 months.

Sampling Method: Patients will be subdivided randomly into two groups :

Group (SI) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus 10 ml of lidocaine 2% for us guided intercostobrachial nerve block.

Group(SP) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus10 ml of lidocaine 2% for us guided PECll block.

Study Procedures:

Following local university ethical committee approval, informed consent will be obtained. Details of the anesthetic technique and the study protocol will be fully explained at the preoperative visit, and written consent will be obtained from each patient before inclusion in the study. The patients has to have normal prothrombin (PT) and partial thromboplastin (PTT) times before the procedure.

In the pre-induction room the patients will be taught how to assess their own pain score using the numerical rating scale (NRS) (0-10; 0 = no pain, 10 = worst imaginable pain) .

On arrival at the operating room, standard monitoring will be established with five lead electrocardiogram, non-invasive blood pressure measurement and pulse oximeter. After insertion of a 20-gauge intravenous cannula in the non operated arm, an intravenous crystalloid solution will be administered. Supplemental oxygen will be supplied through nasal cannula. The oxygen flow will be set at 3 L/ min.

Patients will receive 1-2 md midazolam intravenous as premedication before the block. All blocks will be performed by one of the authors, The patients will be randomly allocated to one of the two groups, either supraclavicular-intercostobrachial group(SI Group) ,or the supraclavicular-Pec 11 group(SP Group) .

The patient in SI Group is placed in a semi-sitting position by elevating the head of bed 45 degrees with the patients head turned to the opposite site to be blocked. The skin of the neck and the upper chest and axilla and medial upper arm will be prepared in an aseptic fashion. Ultrasound examination of the supraclavicular area will be performed using a 38-mm high frequency (9-12 MHz) linear array transducer with the in-plane approach, will receive 25 ml of 0.5% bupivacaine in the supraclavicular area ,then the operated arm will be abducted and externally rotated, and the elbow flexed to 90°. Ultrasound examination of the medial upper arm will be performed using a 38-mm high frequency (9-12 MHz) linear array transducer and the intercosto-brachial nerve is identified and blocked using 10 ml of lidocaine 2% . The patient in SP Group will also have supraclavicular block that will be performed in the same way as the previous group and then patient is placed in the supine position with the arm abducted 90 degrees position to receive Peg 11 lock by injecting 10ml of lidocaine 2% between pectoralis minor and serratus anterior at 3rd rib level using a 38-mm high frequency (9-12 MHz) linear array transducer with the in-plane approach. The sensory and motor blocks will be evaluated every 5 min for 30 min or until blocks will be complete. An adequate surgical anesthesia will be defined as a motor score of ≥1 , with an absence of pinprick sensations in the area of all the four terminal nerves.

The zero time for onset of sensory and motor blocks will be the completion of the LA injection. Sensory block assessment (0, no block 1, loss of sensation of pinprick 2, loss of sensation of touch) will be performed in the innervations of the four nerve areas, radial (radial dorsum of the hand), median (thenar eminence), ulnar (hypothenar eminence),and intercostobrachial (medial upper arm) corresponding to the nerve distributions in the forearm and hand using the pinprick test, and will be compared with the same stimulation on the contra-lateral arm. The degree of motor block will be evaluated by thumb abduction (radial nerve), thumb adduction (ulnar nerve), and thumb opposition (median nerve), using a 3-point scale (0 =normal motor function, 1 = decreased motor strength, 2 = complete motor block). The onset times of the sensory block (the time between the end of the LA injection and the total abolition of the pinprick response) and motor block (time between the end of the LA injection and complete motor block) will be recorded for each nerve. Patients who will not achieve satisfactory levels of anesthesia and will need intraoperative local infiltration will be recorded .Patient in whom the block failed and local infiltration is not enough will receive general anesthesia (propofol 2mg/kg plus fentanyl 1ug/kg and atracurium 0.5mg/kg ) with laryngeal mask airway inserted for mechanical ventilation .

Postoperative pain will be assessed by one of the authors using a visual analog scale (0, no pain; 10, worst pain imaginable). Analgesic for the first complain of pain will be standardized and consisted of 500 mg of oral or intravenous paracetamol given for a pain score of 4 of visual analog scale.The time to first analgesic requirement will be also recorded by the same author.

Heart rate, peripheral oxygen saturation, respiratory rate, and blood pressure will be measured before the supraclavicular block and 5, 10, 20, 30, 45, and 60 min after the block and thereafter every 60 min for 2 h postoperatively. University of Michigan Sedation Scale (UMSS) (1, awake and alert; 2, sedated, responding to verbal stimulus; 3, sedated, responding to strong physical stimulus; 4, not arousable) will be measured first as baseline before the block then at the same time points for measuring vital signs post-block .

Being tested
regional anesthesia for the upper limb

What participants receive

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

  • regional anesthesia for the upper limbProcedure or surgery

    pecs-II block and intercostal nerve block

Study groups in NCT04311255
Study groupRoleWhat they receive
intercostal groupActive comparatorgroup of patient receiving inrercostal nerve block as analgesia
Receives: Procedure: regional anesthesia for the upper limb
pecs groupActive comparatorgroup of patient receiving pectoralis nerve block as analgesia
Receives: Procedure: regional anesthesia for the upper limb

What is being measured

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

  1. the proportion of patients with adequate block (no need for intraoperative local infiltration),

    ratio

    Measured: "through study completion ,an average of one year"

Secondary outcomes (3)
  1. onset of surgical anesthesia

    time

    Measured: "through study completion ,an average of one year"

  2. duration of postoperative analgesia

    time

    Measured: "through study completion ,an average of one year"

  3. the failure rate of the fistulae.

    Ratio

    Measured: "through study completion ,an average of one year"

Timeline

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

  1. First posted17 Mar 2020
  2. Study start13 Apr 2019
  3. Primary completion3 May 2020
  4. Study completion3 May 2020

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 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311255
Sponsor's protocol ID
FMASU R 25/2019
Status last verified
May 2020
First submitted
9 Mar 2020
Last updated
15 May 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing regional anesthesia for the upper limb in people with Best Regional Nerve Block for Creation of Surgical Brachiobasilic Fistula, 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 1 inclusion and 2 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 15 May 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

the proportion of patients with adequate block (no need for intraoperative local infiltration), (time frame: "through study completion ,an average of one year"). 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 15 May 2020.

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