AnalgesiaPhase 2/3NCT04393610
Improving Quality of Bier Block
A Phase 2/3 study testing Lidocaine, Magnesium Sulphate and Fentanyl in people with Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
Intravenous regional anesthesia is one of the well-known techniques of regional anesthesia for short surgical operations on the upper and lower limbs. It was first introduced back in 1908. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Lidocaine, Magnesium Sulphate and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2020to 31 Aug 2020
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for short surgical procedures (30 - 60 minutes) distal to elbow
- age 18-55 years old
- ASA I - II
- both genders
- average weight BMI (25 - 35).
Who cannot join
- seizure diseases
- allergy to the used medicine
- local infection
- patients with sickle cell anemia, Raynaud's disease, scleroderma, myasthenia gravis, significant cardiac or hepatic diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Tarek ElGammal, prof., 0882332278 ext. 002, ethics_committee12@yahoo.com
About this study
Official title: Magnesium Sulphate Versus Fentanyl: Effects on the Quality of Bier Block: Double Blind Placebo Controlled Trial
Intravenous regional anesthesia is one of the well-known techniques of regional anesthesia for short surgical operations on the upper and lower limbs. It was first introduced back in 1908. Later on it was popularized even more for the same purpose by using two tourniquets to isolate an exsanguinated extremity then injection of local anesthesia. It was proved over time to be safe and effective with minimal side effects and complications.
Magnesium sulfate (MgSO4) has been used over the 20th century for prevention and treatment of pre-eclamptic and eclampsia seizures during pregnancy because of its superior safety profile over other drugs used for the same purpose. The specific mechanisms of action of magnesium sulfate still unclear but are probably multi-factorial. It may act as a vasodilator on peripheral as well as cerebral vasculature, to decrease peripheral vascular resistance and/or relieve vasoconstriction. Additionally, it may also protect the blood-brain barrier and limit cerebral edema formation, or it may also act as a central anticonvulsant.
Fentanyl; was first introduced back in 1990 for palliative use as fentanyl patch. Few years later, it became available in different forms of administration being highly lipophilic. Few years later it became the most widely used synthetic opioid in medicine. It is an opioid analgesic with a rapid onset and short duration of action. It is a potent μ-opioid receptor pure agonist. Fentanyl is 50 to 100 times more potent than morphine. Fentanyl has a relatively wide therapeutic index, which makes it a very safe surgical anesthetic drug when monitored carefully.
Read the detailed description
Two Intravenous lines will be inserted one at a distal point on the arm to be blocked and other one in the other arm for fluids infusion. The block will be executed by injecting the target medicine in 10 ml increments in a blinded manner of total of 40 ml (study drugs diluted in normal saline 0.9% solution.
- Group (L): will receive lidocaine 3 mg/kg total of 40 ml (control group)
- Group (M): will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
- Group (F): will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
Equipment: Local anesthetic agent: lidocaine HCl (2%), Rubber tourniquet, IV catheters (20- or 24-gauge), 500-mL or 1-L bag of IV solution (crystalloid), Infusion set, Pneumatic tourniquet, ideally with a double cuff, One Esmarch bandage (about 150 cm in length, 10 cm in width), Syringes.
Preparation: The patient lies in the supine position with the vein selected for block placement is readily accessible. Baseline vital signs are assessed; blood pressure, oxygen saturation, and ECG monitoring. Intravenous access in the non-operated extremity is obtained. Small doses of benzodiazepine for anxiolysis or small aliquots of opioids in case of discomfort will be available if needed. For safety and securing success, pneumatic cuffs will always be checked for air leaks prior to each IVRA procedure. Clinical staff performing the technique should have ready access to intra-lipid in case it is needed.
Technique:
- Secure IV cannula in the extremity opposite to the block side.
- A double pneumatic tourniquet is fixed on a padding layer of soft cloth or cotton with the proximal cuff high on the upper arm.
- An IV cannula is inserted and secured into a peripheral vein of the operative limb, as far distally as possible.
- The entire limb is elevated for 1 to 2 minutes to allow for passive exsanguination. Afterwards, while still keeping the limb high, a rubber (Esmarch) bandage is wrapped around it spirally from distal end proximally till the distal cuff of the double tourniquet.
- The artery is digitally occluded by inflating the proximal cuff 100 mm Hg above systolic arterial blood pressure.
- After reaching the correct pressure, the Esmarch bandage is removed.
- A total of 40 mL of the study medicine according to the protocol is injected slowly in 10 ml increments via the IV catheter.
- After the injection, the arm is lowered to the level of the table. The used IV cannula is removed, and in a sterile manner, pressure is quickly applied over the puncture site.
The onset of anesthesia is + 5 minutes after injection. When the patient reports the tourniquet pain, the distal cuff should be inflated and the proximal cuff is deflated about 20 to 30 minutes after the beginning of anesthesia
- Conditions
- Analgesia
- Keywords
- Magnesium sulphate, Fentanyl, Bier block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Patients will receive lidocaine 3 mg/kg total of 40 ml (control group).
Magnesium SulphateDrug
Patients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
FentanylDrug
Patients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
| Study group | Role | What they receive |
|---|---|---|
| Group (L) | Active comparator | Patients will receive lidocaine 3 mg/kg total of 40 ml (control group) Receives: Drug: Lidocaine |
| Group M | Active comparator | Patients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution. Receives: Drug: Magnesium Sulphate |
| Group F | Active comparator | Patients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Onset of tourniquet pain after deflating proximal tourniquet. VAS consists of a straight line with the endpoints defining extreme limits WHERE 0='no pain AND 10= severe pain.
Measured: 2 hours
Secondary outcomes (4)
3-point scale for motor function
0: normal motor function, 1: reduced motor strength but able to move fingers, 2: complete motor block
Measured: 6 hours
3-point scale for sensory function
0: normal sensation, 1: loss of sensation of cold (analgesia), 2: loss of sensation of touch (anesthesia).
Measured: 6 hours
Total Supplement Analgesia
Total dose of pethidine 10 mg increments that will be used when the patients experience tourniquet pain >3 VAS.
Measured: 24 hours
Complications
Number of patients with any intraoperative or postoperative complications will be recorded and treated.
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 posted19 May 2020
- Study start14 May 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAGAA AHMED HERDAN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393610
- Sponsor's protocol ID
- Quality IVRA
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 21 May 2020
- Results posted
- 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate Versus Fentanyl: Effects on the Quality of Bier Block: Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04393610
- Acronym / sponsor ID
- Quality IVRA
- Conditions
- Analgesia
- Keywords
- Magnesium sulphate, Fentanyl, Bier block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 May 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.
Intravenous regional anesthesia is one of the well-known techniques of regional anesthesia for short surgical operations on the upper and lower limbs. It was first introduced back in 1908. Later on it was popularized even more for the same purpose by using two tourniquets to isolate an exsanguinated extremity then injection of local anesthesia. It was proved over time to be safe and effective with minimal side effects and complications.
Magnesium sulfate (MgSO4) has been used over the 20th century for prevention and treatment of pre-eclamptic and eclampsia seizures during pregnancy because of its superior safety profile over other drugs used for the same purpose. The specific mechanisms of action of magnesium sulfate still unclear but are probably multi-factorial. It may act as a vasodilator on peripheral as well as cerebral vasculature, to decrease peripheral vascular resistance and/or relieve vasoconstriction. Additionally, it may also protect the blood-brain barrier and limit cerebral edema formation, or it may also act as a central anticonvulsant.
Fentanyl; was first introduced back in 1990 for palliative use as fentanyl patch. Few years later, it became available in different forms of administration being highly lipophilic. Few years later it became the most widely used synthetic opioid in medicine. It is an opioid analgesic with a rapid onset and short duration of action. It is a potent μ-opioid receptor pure agonist. Fentanyl is 50 to 100 times more potent than morphine. Fentanyl has a relatively wide therapeutic index, which makes it a very safe surgical anesthetic drug when monitored carefully.
Detailed description
Two Intravenous lines will be inserted one at a distal point on the arm to be blocked and other one in the other arm for fluids infusion. The block will be executed by injecting the target medicine in 10 ml increments in a blinded manner of total of 40 ml (study drugs diluted in normal saline 0.9% solution.
- Group (L): will receive lidocaine 3 mg/kg total of 40 ml (control group)
- Group (M): will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
- Group (F): will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
Equipment: Local anesthetic agent: lidocaine HCl (2%), Rubber tourniquet, IV catheters (20- or 24-gauge), 500-mL or 1-L bag of IV solution (crystalloid), Infusion set, Pneumatic tourniquet, ideally with a double cuff, One Esmarch bandage (about 150 cm in length, 10 cm in width), Syringes.
Preparation: The patient lies in the supine position with the vein selected for block placement is readily accessible. Baseline vital signs are assessed; blood pressure, oxygen saturation, and ECG monitoring. Intravenous access in the non-operated extremity is obtained. Small doses of benzodiazepine for anxiolysis or small aliquots of opioids in case of discomfort will be available if needed. For safety and securing success, pneumatic cuffs will always be checked for air leaks prior to each IVRA procedure. Clinical staff performing the technique should have ready access to intra-lipid in case it is needed.
Technique:
- Secure IV cannula in the extremity opposite to the block side.
- A double pneumatic tourniquet is fixed on a padding layer of soft cloth or cotton with the proximal cuff high on the upper arm.
- An IV cannula is inserted and secured into a peripheral vein of the operative limb, as far distally as possible.
- The entire limb is elevated for 1 to 2 minutes to allow for passive exsanguination. Afterwards, while still keeping the limb high, a rubber (Esmarch) bandage is wrapped around it spirally from distal end proximally till the distal cuff of the double tourniquet.
- The artery is digitally occluded by inflating the proximal cuff 100 mm Hg above systolic arterial blood pressure.
- After reaching the correct pressure, the Esmarch bandage is removed.
- A total of 40 mL of the study medicine according to the protocol is injected slowly in 10 ml increments via the IV catheter.
- After the injection, the arm is lowered to the level of the table. The used IV cannula is removed, and in a sterile manner, pressure is quickly applied over the puncture site.
The onset of anesthesia is + 5 minutes after injection. When the patient reports the tourniquet pain, the distal cuff should be inflated and the proximal cuff is deflated about 20 to 30 minutes after the beginning of anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (L) | Active comparator | Drug: LidocainePatients will receive lidocaine 3 mg/kg total of 40 ml (control group) |
| Group M | Active comparator | Drug: Magnesium SulphatePatients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution. |
| Group F | Active comparator | Drug: FentanylPatients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- scheduled for short surgical procedures (30 - 60 minutes) distal to elbow
- age 18-55 years old
- ASA I - II
- both genders
- average weight BMI (25 - 35).
Key exclusion criteria (4 listed)
- seizure diseases
- allergy to the used medicine
- local infection
- patients with sickle cell anemia, Raynaud's disease, scleroderma, myasthenia gravis, significant cardiac or hepatic diseases.
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 |
|---|---|---|
| LidocainePatients will receive lidocaine 3 mg/kg total of 40 ml (control group). | Drug | Group (L) |
| Magnesium SulphatePatients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution. | Drug | Group M |
| FentanylPatients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution. | Drug | Group F |
Primary outcome
VAS score
Time frame: 2 hours
Onset of tourniquet pain after deflating proximal tourniquet. VAS consists of a straight line with the endpoints defining extreme limits WHERE 0='no pain AND 10= severe pain.
4 secondary outcomes
3-point scale for motor function
Time frame: 6 hours
3-point scale for sensory function
Time frame: 6 hours
Total Supplement Analgesia
Time frame: 24 hours
Complications
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine, Magnesium Sulphate and Fentanyl in people with Analgesia, run by Assiut 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esam Taher, MD (01002228905 ext. 002, ehamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 2 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 21 May 2020.