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Diaphragmatic DisorderNCT04549779

Different Local Anesthetic Volumes in Brachial Plexus Block

A study testing Low volume interscalene brachial plexus block, Intermediate volume interscalene brachial plexus block and High volume interscalene brachial plexus block in people with Diaphragmatic Disorder, run by Tanta 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

This prospective randomized study will be carried out on 75 patients in our university hospitals presented for shoulder arthroscopy under general anesthesia and ultrasound-guided interscalene brachial plexus block. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Diaphragmatic Disorder
What is being tested?
Low volume interscalene brachial plexus block, Intermediate volume interscalene brachial plexus block and High volume interscalene brachial plexus block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteEgypt
Study dates
19 Sep 2020to 24 Aug 2022
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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for shoulder surgeries.

Who cannot join

  • Patients with COPD
  • Sever bronchial asthma
  • BMI > 40 kg/m2
  • Mental dysfunction
  • Allergy to local anesthetics
  • Chronic opioid use
  • Patients refusal

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University Hospitals

    Tanta, Algharbia Governate, 31511

Other trials in Egypt

About this study

Official title: Respiratory Sequelae and Analgesic Efficacy of Different Local Anesthetic Volumes in Ultrasound-guided Interscalene Brachial Plexus Block in Patients Presented for Shoulder Arthroscopy

This prospective randomized study will be carried out on 75 patients in our university hospitals presented for shoulder arthroscopy under general anesthesia and ultrasound-guided interscalene brachial plexus block.

All the patients will receive ultrasound-guided interscalene brachial plexus block with injection of local anesthetic volume according to the group of the patient

Read more
  • Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB
  • Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB
  • Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB After ensuring adequate sensory and motor blockade, general anesthesia will be carried out.

The primary outcome measurement will be the incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion and the secondary outcome will be the postoperative pain scores and opioid consumption.

Read the detailed description

This prospective randomized double-blind study will be carried out on 75 patients who will be presented for shoulder arthroscopy in Tanta university hospitals over 9 months duration (September 2020- May 2021) which will be started immediately after obtaining the approval from the institutional Ethical Committee.

Informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

Patients will be randomly classified using a computer-generated software of randomization into 3 groups:

  • Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB
  • Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB
  • Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB

Anesthetic technique The patients will be assessed preoperatively in the anesthesia clinic through history taking, examination, and appropriate investigation. Pulmonary function tests (PEFR, FEV1, FVC, and FEV1/FVC) will be performed preoperatively. On arrival of patients to the preparation room, an intravenous line will be established and a fluid preload will be started (7 ml/kg of lactated ringer solution) and the patient will be connected to monitor that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature were applied.

The patients will lie supine with ultrasound assessment of the diaphragmatic excursion during quiet breathing, (excluding deep breathing, crying, participants with nasal obstruction, rhinorrhea, or cough, and participants with abdominal pain). Then midazolam 2 mg will be injected slow i.v with the application of nasal cannula (2-3 L/min) to the patient. Then, ultrasound-guided interscalene brachial plexus block will be done under aseptic precaution with an injection of the pre-prepared local anesthetic mixture with its volume according to the group of the patient.

The patients will be monitored for 30 minutes before induction of anesthesia, during which assessment of the sensory blockade will be carried out. The sensory block will be assessed by exposure to cold (ice piece) to the area of the shoulder and the upper arm. The motor block will be evaluated by determining patients ability to abduct the shoulder and flex the elbow against gravity (0 = no block Y full strength, 1 = partial block Y weak but able to abduct or flex against gravity, 2 = complete block Y no activity of muscle group). Preserved sensation to the cold or strength to abduct the shoulder after 30 minutes from performing the block at the area of the shoulder and upper arm will be considered as failed block and the patient will be excluded from the study. Ultrasound assessment of the diaphragmatic excursion during quiet breathing will be done again 30 minutes after performing the block.

Induction of anesthesia will be carried out after 3 minutes of pre-oxygenation through a well-fitted face mask using 80% oxygen by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg to facilitate tracheal intubation. After securing the airway through a suitable sized endotracheal tube, the patient will be connected to a mechanical ventilator with its parameters adjusted to maintain the end-tidal carbon dioxide 34-38 mmHg. Maintenance of the anesthesia will be performed by isoflurane 1.2 % in a low flow gas mixture (1 L/min) composed of oxygen: air 1:1 and incremental doses of atracurium 0.1 mg/kg. A temperature probe will be inserted in the nasopharynx for core temperature monitoring. The depth of anesthesia will be monitored by the bispectral index (Covidien, Mansfield, MA, USA). The BIS values will be kept 40-60. An additional bolus dose of fentanyl 0.5 ug/kg was used in case of increase BIS more than 60 or increase in the heart rate or mean arterial pressure by more than 15 % of the baseline values.

At the end of the surgery, the isoflurane will be switched off with reversal of muscle relaxation by neostigmine 0.05 mg/kg and atropine 0.01 mg/kg with awake tracheal extubation and transfer of the patient to the recovery room for postoperative monitoring and supplementation of oxygen through nasal cannula (2-3 L/min). All the patients will receive 4 mg dexamethasone i.v after induction of anesthesia and 4 mg of ondansetron i.v at the end of the surgery to guard against postoperative nausea and vomiting. Also, paracetamol 1 gm i.v infusion every 6 hours will be given routinely to all patients in the postoperative period. In the PACU, ultrasound-guided assessment of the diaphragmatic excursion will be done. Also, pulmonary function (PEFR, FEV1, FVC, and FEV1/FVC) tests will be repeated before discharging the patients from the recovery room after exclusion of the effect of sedation by the aid of the modified observer¡¦s assessment of alertness.

Bradycardia (heart rate less than 50 b/min) will be managed by atropine 0.3 mg i.v) and hypotension (mean arterial pressure less than 65 mmHg or decrease by more than 20 % of the pre-anesthesia value) will be managed by ephedrine 10 mg i.v and i.v infusion of ringer lactate that may be repeated.

Being tested
Low volume interscalene brachial plexus block, Intermediate volume interscalene brachial plexus block, High volume interscalene brachial plexus block
Keywords
Excursion, Diaphragm, Shoulder arthroscope, Postoperative analgesia

What participants receive

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

  • Low volume interscalene brachial plexus blockProcedure or surgery

    ultrasound-guided interscalene brachial plexus block with 5 ml levobupivacaine 0.25%

  • Intermediate volume interscalene brachial plexus blockProcedure or surgery

    ultrasound-guided interscalene brachial plexus block with 10 ml levobupivacaine 0.25%

  • High volume interscalene brachial plexus blockProcedure or surgery

    ultrasound-guided interscalene brachial plexus block with 15 ml levobupivacaine 0.25%

Study groups in NCT04549779
Study groupRoleWhat they receive
Group I (low volume)Experimentalpatients will receive 5 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block
Receives: Procedure: Low volume interscalene brachial plexus block
Group II (intermediate volume)Experimentalpatients will receive 10 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block
Receives: Procedure: Intermediate volume interscalene brachial plexus block
Group III (high volume)Experimentalpatients will receive 15 ml levobupivacaine 0.25% ultrasound-guided interscalene brachial plexus block.
Receives: Procedure: High volume interscalene brachial plexus block

What is being measured

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

  1. The incidence of diaphragmatic hemiparesis 3

    The incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion

    Measured: After 30 minutes of performing the block

Secondary outcomes (2)
  1. The postoperative pain scores

    Postoperative Numerical rating score (NRS) every 2 hours in the first six hours, then every 4 h till 24 h. When NRS scores reach 4 or more, 3 mg of i.v tramadol will be given and can be repeated if required with calculation of the total postoperative morphine consumption in mg in the first 24 hours after surgery and the time to the first request of rescue analgesia.

    Measured: Within the first 24 hours after surgery

  2. The postoperative opioid consumption

    The total dose of tramadol consumed in the first 24 hours after surgery

    Measured: Within 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 posted16 Sep 2020
  2. Study start19 Sep 2020
  3. Primary completion24 Aug 2021
  4. Study completion24 Aug 2022

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549779
Sponsor's protocol ID
34017/08/20
Status last verified
Jun 2023
First submitted
9 Sep 2020
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.

Questions about this trial

What is this clinical trial studying?

A study testing Low volume interscalene brachial plexus block, Intermediate volume interscalene brachial plexus block and High volume interscalene brachial plexus block in people with Diaphragmatic Disorder, run by Tanta 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 7 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 5 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 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 incidence of diaphragmatic hemiparesis 3 (time frame: After 30 minutes of performing the block). 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 5 Jun 2023.

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