Forearm SurgeriesPhase 2NCT03185351
Midazolam in Supraclavicular Brachial Plexus Block
A Phase 2 study testing Bupivacaine and Midazolam in people with Forearm Surgeries, run by Assiut University at 1 site in Egypt.
Trial summary
An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia in upper extremity surgery, post-operative analgesia and chronic pain management. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Forearm Surgeries
- What is being tested?
- Bupivacaine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2017to 1 Sep 2018
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II physical status patients.
- Age between 18 and 50 years.
- Patients planned for unilateral orthopedic forearm surgeries.
Who cannot join
- Patient refusal
- Any contraindication to regional block (i.e. coagulopathy, infection at the needle insertion site, contralateral pneumothorax or diaphragmatic paralysis)
- Bilateral limb surgery
- Pregnancy
- BMI >35
- Preexisting neuropathy involving the surgical limb
Show all 11Show fewer
- Patients with any known contraindication to study medications
- History of a major psychiatric disorder.
- Chronic pain syndrome.
- History of substance abuse.
- Current opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineural Versus Intravenous Midazolam in Patients Undergoing Forearm Orthopedic Surgeries Using Supraclavicular Brachial Plexus Block
An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia in upper extremity surgery, post-operative analgesia and chronic pain management. In addition to surgical procedure on conscious patients and early eating after the procedure make regional anesthesia more attractive.
Brachial plexus block also maintains stable intraoperative hemodynamic and associated sympathetic block. The sympathetic block decreases postoperative pain, vasospasm and edema. The nerve of brachial plexus may be blocked anywhere along its course. The approach for blocking brachial plexus nerve is interscalene, supraclavicular, infraclavicular and axillary approach.
Read more
Supraclavicular approach for blockade of the brachial plexus is the most commonly used approach in providing surgical anesthesia. In recent years, the technique has gained importance as regional anesthetic technique for surgical, diagnostic and therapeutic purposes in interventional pain management. It includes blocking of the brachial plexus where it is most compactly arranged, with fewer requirements of the anesthetic solution and rapid onset of action. Supraclavicular nerve block is technically easy to perform because of reliable and fixed landmark but association of pneumothorax is a profound complication.
The extent of blockade following injection into the sheath surrounding the brachial plexus may depend on the volume and concentration of local anesthetic (LA) used. Because of bupivacaine long duration of action, it is used most frequently among local anesthetics for BPB.
Inevitably, the effects of single-injection BPB dissipate after several hours unmasking the moderate-to-severe pain of the surgical insult. Efforts to prolong BPB duration by increasing LA dose are limited by their narrow therapeutic window and indeed may not be effective as recent studies have demonstrated equivalent analgesic duration with volumes as low as 5 ml.
Midazolam is known to produce antinociception and potentiate the effect of LA when given in neuraxial block. It produces this effect by its action on Gamma Aminobutyric Acid-A (GABA-A) receptors and also on the peripheral nerves which contain these receptors.
Several studies showed midazolam to be effective when used in intrathecal, epidural and caudal blocks and now recently midazolam with bupivacaine has been found to improve analgesic characteristics in peripheral blocks compared to bupivacaine alone. Due to the high blood concentration of benzodiazepine through conventional routes and profound sedation, proper assessment of analgesic effect was difficult to obtain. With the advent of the less toxic water soluble benzodiazepine (midazolam), it became possible to use it directly over the nerve tissues.
Read the detailed description
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All patients will be kept nil by mouth for at least 6 hours.
- Written consent, coagulation profile, intravenous line, emergency resuscitation equipments including airway devices, advanced cardiac life support drugs for LA toxicity will be available.
- Patients will be monitored using standard monitoring (ECG, non-invasive blood pressure and pulsoximetry)
- All patients will be lightly sedated with 1 mg midazolam I.V. SonoAce 6 ultrasound machine with high frequency linear probe will be used in our study.
Palpation of the subclavian artery in the supraclvicular fossa, just lateral to the sternocledomastoid and above the clavicle (landmark located one finger or 1 cm above the clavicle at the junction of inner 2/3 and outer 1/3 of clavicle).
Position to perform supraclavicular BPB; the anesthetist will stand behind the patient's head, with the ultrasound machine on the side being blocked. The head of the bed is slightly raised to allow the shoulder to drop somewhat the patient's head will be turned to the opposite side, resting directly on the table without a pillow, the hand holding the probe will rest against the patient's jaw, the probe is placed in the supraclavicular fossa in a coronal oblique plane, the needle will be inserted from the lateral side, The pulsating hypoechoic supraclavicular artery is identified, lying above the hyperechoic first rib, the probe is then angled until both the first rib and the pleura are also seen simultaneously, The nerve structures (trunks or divisions) are usually visualized as a collection of hypoechoic round structures (a bunch of grapes) lying superior and postero-lateral to the subclavian artery. A 3 cm long 22 G needle with 10 cc syringe filled with respective LA agent will be inserted directing downward, forward and medially at the angle of 20° to the skin till the parasthesia elicited in the hand or the 1st rib hit, then the needle will be fixed at that point. After the negative aspiration respective agents will be given. A gentle massage over the area will be done with an idea of uniform spread. All brachial plexus injections will be administered slowly with repeated aspiration to prevent or detect early intravascular injection. The end of the injection will be considered time 0.
- Conditions
- Forearm Surgeries
- Being tested
- Bupivacaine, Midazolam
- Keywords
- midazolam, brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 ml of 0.5% bupivacaine using supraclavicular BPB.
MidazolamDrug
midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB
MidazolamDrug
0.03 mg/kg of midazolam by I.V. route
| Study group | Role | What they receive |
|---|---|---|
| BUPIVACAINE | Active comparator | patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB.
. Receives: Drug: Bupivacaine |
| BUPIVACAINE and midazolam | Active comparator | patients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB. Receives: Drug: Bupivacaine; Drug: Midazolam |
| BUPIVACAINE and i.v midazolam | Active comparator | patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block Receives: Drug: Bupivacaine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating pain scale graded from 0 to 10
postoperative analgesic efficacy of ultrasound guided supraclavicular BPB
Measured: 24 hours
Secondary outcomes (2)
Motor blockade
Modified Bromage Score
Measured: 24 hours
Sedation Score
(Awake and alert -1, Sedated and responding to verbal command-2, Sedated and responding to mild stimulus-3, Sedated and responding to moderate to severe physical stimulus-4).
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 posted14 Jun 2017
- Study start14 Jun 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm SurgeriesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group A: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB. * Group B: patients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB. * Group C: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
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
- NCT03185351
- Sponsor's protocol ID
- brachial plexus block
- Status last verified
- Sep 2018
- First submitted
- 21 May 2017
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Versus Intravenous Midazolam in Patients Undergoing Forearm Orthopedic Surgeries Using Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03185351
- Acronym / sponsor ID
- brachial plexus block
- Conditions
- Forearm Surgeries
- Keywords
- midazolam, brachial plexus block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 14 Jun 2017 (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.
An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia in upper extremity surgery, post-operative analgesia and chronic pain management. In addition to surgical procedure on conscious patients and early eating after the procedure make regional anesthesia more attractive.
Brachial plexus block also maintains stable intraoperative hemodynamic and associated sympathetic block. The sympathetic block decreases postoperative pain, vasospasm and edema. The nerve of brachial plexus may be blocked anywhere along its course. The approach for blocking brachial plexus nerve is interscalene, supraclavicular, infraclavicular and axillary approach.
Supraclavicular approach for blockade of the brachial plexus is the most commonly used approach in providing surgical anesthesia. In recent years, the technique has gained importance as regional anesthetic technique for surgical, diagnostic and therapeutic purposes in interventional pain management. It includes blocking of the brachial plexus where it is most compactly arranged, with fewer requirements of the anesthetic solution and rapid onset of action. Supraclavicular nerve block is technically easy to perform because of reliable and fixed landmark but association of pneumothorax is a profound complication.
The extent of blockade following injection into the sheath surrounding the brachial plexus may depend on the volume and concentration of local anesthetic (LA) used. Because of bupivacaine long duration of action, it is used most frequently among local anesthetics for BPB.
Inevitably, the effects of single-injection BPB dissipate after several hours unmasking the moderate-to-severe pain of the surgical insult. Efforts to prolong BPB duration by increasing LA dose are limited by their narrow therapeutic window and indeed may not be effective as recent studies have demonstrated equivalent analgesic duration with volumes as low as 5 ml.
Midazolam is known to produce antinociception and potentiate the effect of LA when given in neuraxial block. It produces this effect by its action on Gamma Aminobutyric Acid-A (GABA-A) receptors and also on the peripheral nerves which contain these receptors.
Several studies showed midazolam to be effective when used in intrathecal, epidural and caudal blocks and now recently midazolam with bupivacaine has been found to improve analgesic characteristics in peripheral blocks compared to bupivacaine alone. Due to the high blood concentration of benzodiazepine through conventional routes and profound sedation, proper assessment of analgesic effect was difficult to obtain. With the advent of the less toxic water soluble benzodiazepine (midazolam), it became possible to use it directly over the nerve tissues.
Detailed description
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All patients will be kept nil by mouth for at least 6 hours.
- Written consent, coagulation profile, intravenous line, emergency resuscitation equipments including airway devices, advanced cardiac life support drugs for LA toxicity will be available.
- Patients will be monitored using standard monitoring (ECG, non-invasive blood pressure and pulsoximetry)
- All patients will be lightly sedated with 1 mg midazolam I.V. SonoAce 6 ultrasound machine with high frequency linear probe will be used in our study.
Palpation of the subclavian artery in the supraclvicular fossa, just lateral to the sternocledomastoid and above the clavicle (landmark located one finger or 1 cm above the clavicle at the junction of inner 2/3 and outer 1/3 of clavicle).
Position to perform supraclavicular BPB; the anesthetist will stand behind the patient's head, with the ultrasound machine on the side being blocked. The head of the bed is slightly raised to allow the shoulder to drop somewhat the patient's head will be turned to the opposite side, resting directly on the table without a pillow, the hand holding the probe will rest against the patient's jaw, the probe is placed in the supraclavicular fossa in a coronal oblique plane, the needle will be inserted from the lateral side, The pulsating hypoechoic supraclavicular artery is identified, lying above the hyperechoic first rib, the probe is then angled until both the first rib and the pleura are also seen simultaneously, The nerve structures (trunks or divisions) are usually visualized as a collection of hypoechoic round structures (a bunch of grapes) lying superior and postero-lateral to the subclavian artery. A 3 cm long 22 G needle with 10 cc syringe filled with respective LA agent will be inserted directing downward, forward and medially at the angle of 20° to the skin till the parasthesia elicited in the hand or the 1st rib hit, then the needle will be fixed at that point. After the negative aspiration respective agents will be given. A gentle massage over the area will be done with an idea of uniform spread. All brachial plexus injections will be administered slowly with repeated aspiration to prevent or detect early intravascular injection. The end of the injection will be considered time 0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- * Group A: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB. * Group B: patients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB. * Group C: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block.
| Arm | Type | Receives |
|---|---|---|
| BUPIVACAINE | Active comparator | Drug: Bupivacainepatients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB. . |
| BUPIVACAINE and midazolam | Active comparator | Drug: Bupivacaine, Drug: Midazolampatients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB. |
| BUPIVACAINE and i.v midazolam | Active comparator | Drug: Bupivacaine, Drug: Midazolampatients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II physical status patients.
- Age between 18 and 50 years.
- Patients planned for unilateral orthopedic forearm surgeries.
Key exclusion criteria (11 listed)
- Patient refusal
- Any contraindication to regional block (i.e. coagulopathy, infection at the needle insertion site, contralateral pneumothorax or diaphragmatic paralysis)
- Bilateral limb surgery
- Pregnancy
- BMI >35
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 |
|---|---|---|
| Bupivacaine20 ml of 0.5% bupivacaine using supraclavicular BPB. | Drug | BUPIVACAINE, BUPIVACAINE and i.v midazolam, BUPIVACAINE and midazolam |
| Midazolammidazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB | Drug | BUPIVACAINE and midazolam |
| Midazolam0.03 mg/kg of midazolam by I.V. route | Drug | BUPIVACAINE and i.v midazolam |
Primary outcome
Numerical rating pain scale graded from 0 to 10
Time frame: 24 hours
postoperative analgesic efficacy of ultrasound guided supraclavicular BPB
2 secondary outcomes
Motor blockade
Time frame: 24 hours
Sedation Score
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 24 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine and Midazolam in people with Forearm Surgeries, 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 3 inclusion and 11 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 24 Sep 2018. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numerical rating pain scale graded from 0 to 10 (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 24 Sep 2018.