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.
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.
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.
- Conditions
- Diaphragmatic Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Group I (low volume) | Experimental | patients 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) | Experimental | patients 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) | Experimental | patients 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.
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)
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
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.
- First posted16 Sep 2020
- Study start19 Sep 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, Principal investigator, Tanta University
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04549779
- Acronym / sponsor ID
- 34017/08/20
- Conditions
- Diaphragmatic Disorder
- Keywords
- Excursion, Diaphragm, Shoulder arthroscope, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 16 Sep 2020 (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.
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
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (low volume) | Experimental | Procedure: Low volume interscalene brachial plexus blockpatients will receive 5 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block |
| Group II (intermediate volume) | Experimental | Procedure: Intermediate volume interscalene brachial plexus blockpatients will receive 10 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block |
| Group III (high volume) | Experimental | Procedure: High volume interscalene brachial plexus blockpatients will receive 15 ml levobupivacaine 0.25% ultrasound-guided interscalene brachial plexus block. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for shoulder surgeries.
Key exclusion criteria (7 listed)
- Patients with COPD
- Sever bronchial asthma
- BMI > 40 kg/m2
- Mental dysfunction
- Allergy to local anesthetics
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 |
|---|---|---|
| Low volume interscalene brachial plexus blockultrasound-guided interscalene brachial plexus block with 5 ml levobupivacaine 0.25% | Procedure or surgery | Group I (low volume) |
| Intermediate volume interscalene brachial plexus blockultrasound-guided interscalene brachial plexus block with 10 ml levobupivacaine 0.25% | Procedure or surgery | Group II (intermediate volume) |
| High volume interscalene brachial plexus blockultrasound-guided interscalene brachial plexus block with 15 ml levobupivacaine 0.25% | Procedure or surgery | Group III (high volume) |
Primary outcome
The incidence of diaphragmatic hemiparesis 3
Time frame: After 30 minutes of performing the block
The incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion
2 secondary outcomes
The postoperative pain scores
Time frame: Within the first 24 hours after surgery
The postoperative opioid consumption
Time frame: Within 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 5 Jun 2023.
- Individual participant dataSharing planned: Yes. The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Related trials for Diaphragmatic Disorder
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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.
Sameh Abdelkhalik principal investigator
Tanta University
1 site in 1 country: see every site and its status.
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.