Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549779
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2020-09-09
Brief Title:
Different Local Anesthetic Volumes in Brachial Plexus Block
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 025 ISPB
Group II 25 patients patients will receive 10 ml levobupivacaine 025 ISPB
Group III 25 patients patients will receive 15 ml levobupivacaine 025 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
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 025 ISPB
Group II 25 patients patients will receive 10 ml levobupivacaine 025 ISPB
Group III 25 patients patients will receive 15 ml levobupivacaine 025 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 025 ISPB
Group II 25 patients patients will receive 10 ml levobupivacaine 025 ISPB
Group III 25 patients patients will receive 15 ml levobupivacaine 025 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 FEV1FVC 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 mlkg 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 iv with the application of nasal cannula 2-3 Lmin 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 ugkg propofol 15 mgkg and atracurium 05 mgkg 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 12 in a low flow gas mixture 1 Lmin composed of oxygen air 11 and incremental doses of atracurium 01 mgkg 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 05 ugkg 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 005 mgkg and atropine 001 mgkg 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 Lmin All the patients will receive 4 mg dexamethasone iv after induction of anesthesia and 4 mg of ondansetron iv at the end of the surgery to guard against postoperative nausea and vomiting Also paracetamol 1 gm iv 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 FEV1FVC 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 observers assessment of alertness
Bradycardia heart rate less than 50 bmin will be managed by atropine 03 mg iv 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 iv and iv infusion of ringer lactate that may be repeated
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 025 ISPB
Group II 25 patients patients will receive 10 ml levobupivacaine 025 ISPB
Group III 25 patients patients will receive 15 ml levobupivacaine 025 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 FEV1FVC 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 mlkg 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 iv with the application of nasal cannula 2-3 Lmin 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 ugkg propofol 15 mgkg and atracurium 05 mgkg 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 12 in a low flow gas mixture 1 Lmin composed of oxygen air 11 and incremental doses of atracurium 01 mgkg 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 05 ugkg 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 005 mgkg and atropine 001 mgkg 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 Lmin All the patients will receive 4 mg dexamethasone iv after induction of anesthesia and 4 mg of ondansetron iv at the end of the surgery to guard against postoperative nausea and vomiting Also paracetamol 1 gm iv 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 FEV1FVC 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 observers assessment of alertness
Bradycardia heart rate less than 50 bmin will be managed by atropine 03 mg iv 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 iv and iv infusion of ringer lactate that may be repeated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None