Verapamil in Supraclavicular Brachial Plexus Block

NCT ID: NCT05183997

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Regional Anesthesia Morbidity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group (A) : 30 patients (control group):

Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .

Group Type PLACEBO_COMPARATOR

complete blood count

Intervention Type DIAGNOSTIC_TEST

laboratory test

prothrombin time

Intervention Type DIAGNOSTIC_TEST

laboratory test

prothrombin concentration

Intervention Type DIAGNOSTIC_TEST

laboratory test

Group (B) : 30 patients (verapamil group):

Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.

Group Type EXPERIMENTAL

complete blood count

Intervention Type DIAGNOSTIC_TEST

laboratory test

prothrombin time

Intervention Type DIAGNOSTIC_TEST

laboratory test

prothrombin concentration

Intervention Type DIAGNOSTIC_TEST

laboratory test

Verapamil

Intervention Type DRUG

drug will be add to prolong the effect of regional block

Interventions

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complete blood count

laboratory test

Intervention Type DIAGNOSTIC_TEST

prothrombin time

laboratory test

Intervention Type DIAGNOSTIC_TEST

prothrombin concentration

laboratory test

Intervention Type DIAGNOSTIC_TEST

Verapamil

drug will be add to prolong the effect of regional block

Intervention Type DRUG

Other Intervention Names

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Isoptin

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :

1. fracture radius and ulna.
2. cut wrists.

Exclusion Criteria

1. allergy to the study drugs,
2. skin infection at site of needle puncture,
3. significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hosny Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Essam Sharkawy, MD

Role: CONTACT

00201223497642

Abdelraheem Mahmoud, MD

Role: CONTACT

00201000032655

References

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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.

Reference Type BACKGROUND
PMID: 24413428 (View on PubMed)

Knezevic 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.

Reference Type BACKGROUND
PMID: 25675053 (View on PubMed)

Popping 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.

Reference Type BACKGROUND
PMID: 19602964 (View on PubMed)

Malmberg 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.

Reference Type BACKGROUND
PMID: 8046458 (View on PubMed)

Brose 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.

Reference Type BACKGROUND
PMID: 9303259 (View on PubMed)

Other Identifiers

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vsbpb

Identifier Type: -

Identifier Source: org_study_id

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