Retroclavicular Block in Vascular Surgey

NCT ID: NCT06406712

Last Updated: 2024-06-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-02-01

Brief Summary

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The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform .

The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.

Detailed Description

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Regional anesthesia (RA) offers several advantages over general anesthesia (GA) for upper limb orthopedic surgery. One of the advantages is the improvement in postoperative pain, which leads to decreased use of postoperative opioids needs and reduces the recovery time for patients . A variety of approaches for regional blockade for upper extremity surgery have been described.

Dexamethasone is a corticosteroid drug that has been used as an adjuvant to reduce postoperative pain.

The use of peri neural dexamethasone (i.e. dexamethasone added to the local anesthesia solution) as an adjuvant to peripheral nerve block to improve analgesia provided by local anesthetic alone . Peri neural dexamethasone, as an adjuvant to peripheral nerve block, has been associated with faster onset of anesthesia , longer duration of anesthesia/analgesia decreased postoperative pain intensity and decreased postoperative analgesia requirements compared with local anaesthetic alone . The exact mechanism by which dexamethasone reduces pain is not known. The decrease in pain intensity and the prolonged analgesia attained with the use of perineural dexamethasone may be the result of a local, or systemic action, or both . Dexamethasone may act locally on glucocorticosteroid receptors to induce vasoconstriction, thereby decreasing systemic absorption of local anaesthetics . Other potential mechanisms of action include suppression of C-fibre transmission of pain signals and direct action on the nerve cell to reduce neural discharge . Dexamethasone may act systemically by reducing the inflammatory response caused by surgical tissue injury .

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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dexamethasone with bupivacaine in retroclavicular block

40patients received 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml of dexamethasone)

Group Type ACTIVE_COMPARATOR

retroclavicular block

Intervention Type OTHER

regional anesthesia

bupivacaine in retroclavicular block (control group)

: 40patients received. 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml saline

Group Type ACTIVE_COMPARATOR

retroclavicular block

Intervention Type OTHER

regional anesthesia

Interventions

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retroclavicular block

regional anesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing upper limb vascular surgey .

Exclusion Criteria

* \- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
* Altered conscious level.
* Pregnancy.
* Body mass index (BMI \> 35).
* Patients who have difficulty understanding the study protocol.
* Patients who have any known contraindication to study medications.
* Patient refusal.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ismail Abdelsabour

lecture of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed ismail, lecture

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine , new valley university

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed ismail, lecture

Role: CONTACT

01097845491

Facility Contacts

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hassan abdel lataif, prof

Role: primary

Other Identifiers

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new valley anesthesia g2

Identifier Type: -

Identifier Source: org_study_id

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