Regional Anesthesia MorbidityNCT05183997
Verapamil in Supraclavicular Brachial Plexus Block
A study testing complete blood count, prothrombin time and prothrombin concentration in people with Regional Anesthesia Morbidity, run by Assiut University.
Trial summary
Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- complete blood count, prothrombin time and prothrombin concentration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Feb 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :
- fracture radius and ulna.
- cut wrists.
Who cannot join
- allergy to the study drugs,
- skin infection at site of needle puncture,
- significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Verapamil as an Adjuvant to Bupivacaine in Supraclavicular Brachial Plexus Block Guided by Ultrasound for Forearm and Hand Surgeries
Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.
Read the detailed description
Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, a2 agonists (i.e. clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone.
The investigators will use calcium channel blocker as adjuvant to bupivacaine in supraclavicular block. Calcium plays an important role in analgesia produced by local anesthetics. The activation of N-methyl-D-aspartate receptors may lead to calcium entry into cells and potentiation of spinal cord and plays a role in pain formation. Hence, calcium channel blockers may prevent central sensitization and provide better sensory motor block characteristics. Verapamil, a calcium channel blocker can potentiate analgesic action of local anesthetics and reduce postoperative pain and analgesic consumption. Few studies were there using 2.5 mg of verapamil, showing no effect on onset and duration of sensory motor block. Hence, the investigators have used 5 mg of verapamil as adjuvant to bupivacaine. The primary aim of the study was to know whether verapamil (5 mg) as adjuvant to bupivacaine in supraclavicular brachial plexus block would delay the need of rescue analgesia.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- complete blood count, prothrombin time, prothrombin concentration, Verapamil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood countDiagnostic test
laboratory test
prothrombin timeDiagnostic test
laboratory test
prothrombin concentrationDiagnostic test
laboratory test
VerapamilDrug
Also called Isoptin
drug will be add to prolong the effect of regional block
| Study group | Role | What they receive |
|---|---|---|
| Group (A) : 30 patients (control group): | Placebo comparator | Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline . Receives: Diagnostic Test: complete blood count; Diagnostic Test: prothrombin time; Diagnostic Test: prothrombin concentration |
| Group (B) : 30 patients (verapamil group): | Experimental | Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline. Receives: Diagnostic Test: complete blood count; Diagnostic Test: prothrombin time; Diagnostic Test: prothrombin concentration; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative analgesia.
blinded observer will collect the Visual Analogue Score (VAS) for pain scored from Zero to ten where 0= no pain and 10 = the worst pain imaginable for acute post-operative pain.
Measured: in first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hosny Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183997
- Sponsor's protocol ID
- vsbpb
- Status last verified
- Jan 2022
- First submitted
- 8 Oct 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
PubMed 24413428Knezevic NN, Anantamongkol U, Candido KD. Perineural dexamethasone added to local anesthesia for brachial plexus block improves pain but delays block onset and motor blockade recovery. Pain Physician. 2015 Jan-Feb;18(1):1-14.
PubMed 25675053Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.
PubMed 19602964Malmberg AB, Yaksh TL. Voltage-sensitive calcium channels in spinal nociceptive processing: blockade of N- and P-type channels inhibits formalin-induced nociception. J Neurosci. 1994 Aug;14(8):4882-90. doi: 10.1523/JNEUROSCI.14-08-04882.1994.
PubMed 8046458Brose WG, Gutlove DP, Luther RR, Bowersox SS, McGuire D. Use of intrathecal SNX-111, a novel, N-type, voltage-sensitive, calcium channel blocker, in the management of intractable brachial plexus avulsion pain. Clin J Pain. 1997 Sep;13(3):256-9. doi: 10.1097/00002508-199709000-00012.
PubMed 9303259
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Verapamil as an Adjuvant to Bupivacaine in Supraclavicular Brachial Plexus Block Guided by Ultrasound for Forearm and Hand Surgeries
- ClinicalTrials.gov ID
- NCT05183997
- Acronym / sponsor ID
- vsbpb
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 11 Jan 2022 (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.
Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.
Detailed description
Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, a2 agonists (i.e. clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone.
The investigators will use calcium channel blocker as adjuvant to bupivacaine in supraclavicular block. Calcium plays an important role in analgesia produced by local anesthetics. The activation of N-methyl-D-aspartate receptors may lead to calcium entry into cells and potentiation of spinal cord and plays a role in pain formation. Hence, calcium channel blockers may prevent central sensitization and provide better sensory motor block characteristics. Verapamil, a calcium channel blocker can potentiate analgesic action of local anesthetics and reduce postoperative pain and analgesic consumption. Few studies were there using 2.5 mg of verapamil, showing no effect on onset and duration of sensory motor block. Hence, the investigators have used 5 mg of verapamil as adjuvant to bupivacaine. The primary aim of the study was to know whether verapamil (5 mg) as adjuvant to bupivacaine in supraclavicular brachial plexus block would delay the need of rescue analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) : 30 patients (control group): | Placebo comparator | Diagnostic Test: complete blood count, Diagnostic Test: prothrombin time, Diagnostic Test: prothrombin concentrationPatient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline . |
| Group (B) : 30 patients (verapamil group): | Experimental | Diagnostic Test: complete blood count, Diagnostic Test: prothrombin time, Diagnostic Test: prothrombin concentration, Drug: VerapamilPatient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :
Key exclusion criteria (3 listed)
- allergy to the study drugs,
- skin infection at site of needle puncture,
- significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.
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 |
|---|---|---|
| complete blood countlaboratory test | Diagnostic test | Group (A) : 30 patients (control group):, Group (B) : 30 patients (verapamil group): |
| prothrombin timelaboratory test | Diagnostic test | Group (A) : 30 patients (control group):, Group (B) : 30 patients (verapamil group): |
| prothrombin concentrationlaboratory test | Diagnostic test | Group (A) : 30 patients (control group):, Group (B) : 30 patients (verapamil group): |
| VerapamilAlso: Isoptindrug will be add to prolong the effect of regional block | Drug | Group (B) : 30 patients (verapamil group): |
Primary outcome
duration of postoperative analgesia.
Time frame: in first 24 hours
blinded observer will collect the Visual Analogue Score (VAS) for pain scored from Zero to ten where 0= no pain and 10 = the worst pain imaginable for acute post-operative pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 24413428Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
- Background: PubMed 25675053Knezevic NN, Anantamongkol U, Candido KD. Perineural dexamethasone added to local anesthesia for brachial plexus block improves pain but delays block onset and motor blockade recovery. Pain Physician. 2015 Jan-Feb;18(1):1-14.
- Background: PubMed 19602964Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.
- Background: PubMed 8046458Malmberg AB, Yaksh TL. Voltage-sensitive calcium channels in spinal nociceptive processing: blockade of N- and P-type channels inhibits formalin-induced nociception. J Neurosci. 1994 Aug;14(8):4882-90. doi: 10.1523/JNEUROSCI.14-08-04882.1994.
- Background: PubMed 9303259Brose WG, Gutlove DP, Luther RR, Bowersox SS, McGuire D. Use of intrathecal SNX-111, a novel, N-type, voltage-sensitive, calcium channel blocker, in the management of intractable brachial plexus avulsion pain. Clin J Pain. 1997 Sep;13(3):256-9. doi: 10.1097/00002508-199709000-00012.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing complete blood count, prothrombin time and prothrombin concentration in people with Regional Anesthesia Morbidity, run by Assiut University.
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 3 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essam Sharkawy, MD (00201223497642, essamsas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of postoperative analgesia. (time frame: in first 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183997, which also lists 5 linked publications.
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 11 Jan 2022.