Post Operative PainNCT06162806
Evaluation of Adding Magnesium Sulfate to (Fentanyl/Bupivacaine)Bi-mixture in Caudal Block
A study testing ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl and ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl) in people with Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
this is a randomized controlled study ,patients will be randomly divided into 2 groups , Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl) Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl and ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2023to 6 Mar 2024
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aging from 2-12 years
- undergoing lower abdominal urological surgeries not exceeding 3 hours
- ASA I and II
Who cannot join
- parents refusal to participate in the study
- deformities in the spine
- coagulopathy
- localized infection at site of needle insertion
- known allergic to any of the used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Adding Magnesium Sulfate to (Fentanyl/Bupivacaine)Bi-mixture as an Adjuvant to Local Anesthesia in Caudal Block Among Pediatrics in Lower Abdominal Urological Surgeries. a Prospective Randomized Comparative Study
this is a randomized controlled study ,patients will be randomly divided into 2 groups , Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl)
Read the detailed description
A total of 50 pediatric patients undergoing lower abdominal urological surgeries will be enrolled in this prospective randomized controlled (RCT) study.
I- Randomization:
All included subjects will be randomly allocated and will be divided into two groups; (Group A): will receive [Fentanyl / Bupivacaine], and (Group B): will receive magnesium sulfate added to the previous bi-mixture [Fentanyl / Bupivacaine]. Using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique. There will be no restrictions or stratification in the randomization process. The allocation envelope will be opened by the assistant lecturer at the time of anesthetic preparation. Also, the drug preparation will be conducted by an anesthetist who will not involve in any of the study collection data. Finally, the data will be analyzed on an intention-to-treat basis and included all patients who were randomly assigned.
II- Study protocol
- Pre-operative preparation All children will be anaesthetized in accordance with the local policy of the Abou El-Resh pediatric hospital-Cairo University's pediatric anesthetic unit. Except for oral clear fluid intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, their age and body weight will be recorded as well.
- Intra-operative management
Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
Technique
After induction of anesthesia, each child will be placed in the left decubitus position with hips flexed at 90 degrees, under complete aseptic precautions, disinfecting the back with chlorhexidine and alcohol, then identification of sacral hiatus is attempted by palpation.
By the aid of US, using a linear transducer placed transversely at the midline to obtain the transverse view of sacral hiatus. Between the sacral cornua are two band-like hyperechoic structures; the superficial one is the SCL, and the deep one is the dorsal surface of sacral bone. The sacral hiatus is the hypoechoic region between the 2 band-like hyperechoic structures. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus.
Under longitudinal view, the block needle is inserted using the "in-plane" technique. it is suggested that advancement of needle tip beyond the apex of sacral hiatus be limited to 5 mm to avoid dural puncture because the distance between the apex of sacral hiatus and dural sac termination can be as short as less than 6 mm. [8]
(Group A):
Patients in this anesthetic group will receive 0.5 µ/kg fentanyl + 1ml/kg Bupivacaine 0.25% (Group B): Patients in this anesthetic group will receive 50 mg magnesium added to the (0.5 µ/kg fentanyl +1ml/kg Bupivacaine 0.25%) Bi-mixture.
After receiving caudal block the patient will be turned to the supine position and surgical incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, oxygen saturation and respiratory rate will be carried out from the moment of injection at timely intervals intraoperative. Pain assessment using FLACC score will then follow till 12 hours post-operative.
The time passed between the entrance of the needle into the skin and the injection's completion is referred to as caudal block performance time.
If there is an increase in heart rate or mean arterial pressure of 20% of the baseline values after skin incision, then it will be considered as a failed block and these patients will be excluded from the study and fentanyl of 1µ/kg will be given to provide analgesia
- Conditions
- Post Operative Pain
- Being tested
- ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl, ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of FentanylProcedure or surgery
injection of local anesthetic mixture(Bupivacaine +Fentanyl ) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space
ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)Procedure or surgery
injection of local anesthetic mixture(Bupivacaine +Fentanyl +magnesium sulfate) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | This group of patients will receive ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine +0.5ulkg fentanyl Receives: Procedure: ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl |
| Group B | Experimental | This group of patients will receive ultrasound guided caudal epidural block with 50 mg of magnesium added to (1ml/kg Bupivacaine+0.5ulkg fentanyl)bi-mixture Receives: Procedure: ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first requirement of rescue analgesia
the time after the operation when the patient need rescue analgesia
Measured: 24 hours
Secondary outcomes (2)
postoperative opioid analgesia consumption
the total amount of opioids consumed by the patient postoperative
Measured: 24 hours
complications
occurrence of any postoperative complications related to the caudal block
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start14 Dec 2023
- Primary completion27 Feb 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd elmoneim Adel Abd elmoneim, Cairo University
- Investigators
- Ahmed H Farouk, lecturer, Study director, Anesthesia department , cairo universitysherif M soaida, assprofessor, Principal investigator, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162806
- Sponsor's protocol ID
- MS-454-2022
- Status last verified
- Mar 2024
- First submitted
- 23 Sep 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adding Magnesium Sulfate to (Fentanyl/Bupivacaine)Bi-mixture as an Adjuvant to Local Anesthesia in Caudal Block Among Pediatrics in Lower Abdominal Urological Surgeries. a Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06162806
- Acronym / sponsor ID
- MS-454-2022
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 8 Dec 2023 (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 is a randomized controlled study ,patients will be randomly divided into 2 groups , Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl)
Detailed description
A total of 50 pediatric patients undergoing lower abdominal urological surgeries will be enrolled in this prospective randomized controlled (RCT) study.
I- Randomization:
All included subjects will be randomly allocated and will be divided into two groups; (Group A): will receive [Fentanyl / Bupivacaine], and (Group B): will receive magnesium sulfate added to the previous bi-mixture [Fentanyl / Bupivacaine]. Using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique. There will be no restrictions or stratification in the randomization process. The allocation envelope will be opened by the assistant lecturer at the time of anesthetic preparation. Also, the drug preparation will be conducted by an anesthetist who will not involve in any of the study collection data. Finally, the data will be analyzed on an intention-to-treat basis and included all patients who were randomly assigned.
II- Study protocol
- Pre-operative preparation All children will be anaesthetized in accordance with the local policy of the Abou El-Resh pediatric hospital-Cairo University's pediatric anesthetic unit. Except for oral clear fluid intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, their age and body weight will be recorded as well.
- Intra-operative management
Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
Technique
After induction of anesthesia, each child will be placed in the left decubitus position with hips flexed at 90 degrees, under complete aseptic precautions, disinfecting the back with chlorhexidine and alcohol, then identification of sacral hiatus is attempted by palpation.
By the aid of US, using a linear transducer placed transversely at the midline to obtain the transverse view of sacral hiatus. Between the sacral cornua are two band-like hyperechoic structures; the superficial one is the SCL, and the deep one is the dorsal surface of sacral bone. The sacral hiatus is the hypoechoic region between the 2 band-like hyperechoic structures. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus.
Under longitudinal view, the block needle is inserted using the "in-plane" technique. it is suggested that advancement of needle tip beyond the apex of sacral hiatus be limited to 5 mm to avoid dural puncture because the distance between the apex of sacral hiatus and dural sac termination can be as short as less than 6 mm. [8]
(Group A):
Patients in this anesthetic group will receive 0.5 µ/kg fentanyl + 1ml/kg Bupivacaine 0.25% (Group B): Patients in this anesthetic group will receive 50 mg magnesium added to the (0.5 µ/kg fentanyl +1ml/kg Bupivacaine 0.25%) Bi-mixture.
After receiving caudal block the patient will be turned to the supine position and surgical incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, oxygen saturation and respiratory rate will be carried out from the moment of injection at timely intervals intraoperative. Pain assessment using FLACC score will then follow till 12 hours post-operative.
The time passed between the entrance of the needle into the skin and the injection's completion is referred to as caudal block performance time.
If there is an increase in heart rate or mean arterial pressure of 20% of the baseline values after skin incision, then it will be considered as a failed block and these patients will be excluded from the study and fentanyl of 1µ/kg will be given to provide analgesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of FentanylThis group of patients will receive ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine +0.5ulkg fentanyl |
| Group B | Experimental | Procedure: ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)This group of patients will receive ultrasound guided caudal epidural block with 50 mg of magnesium added to (1ml/kg Bupivacaine+0.5ulkg fentanyl)bi-mixture |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pediatric patients aging from 2-12 years
- undergoing lower abdominal urological surgeries not exceeding 3 hours
- ASA I and II
Key exclusion criteria (5 listed)
- parents refusal to participate in the study
- deformities in the spine
- coagulopathy
- localized infection at site of needle insertion
- known allergic to any of the used drugs
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 |
|---|---|---|
| ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanylinjection of local anesthetic mixture(Bupivacaine +Fentanyl ) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space | Procedure or surgery | Group A |
| ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)injection of local anesthetic mixture(Bupivacaine +Fentanyl +magnesium sulfate) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space | Procedure or surgery | Group B |
Primary outcome
time to first requirement of rescue analgesia
Time frame: 24 hours
the time after the operation when the patient need rescue analgesia
2 secondary outcomes
postoperative opioid analgesia consumption
Time frame: 24 hours
complications
Time frame: 24 hours
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 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Ahmed H Farouk, lecturer study director
Anesthesia department , cairo university
sherif M soaida, assprofessor principal investigator
Anesthesia department , Cairo 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 ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl and ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl) in people with Post Operative Pain, run by Cairo 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 3 inclusion and 5 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 12 Mar 2024. 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?
time to first requirement of rescue analgesia (time frame: 24 hours). 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 12 Mar 2024.