Perineural Dexamethasone, Dexmedetomidine, or Their Combination to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block

NCT ID: NCT07299877

Last Updated: 2025-12-23

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-28

Study Completion Date

2026-10-15

Brief Summary

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Dexmedetomidine, an α2 adrenoceptor agonist, and dexamethasone, a potent anti-inflammatory steroid, are commonly used, effective, and safe adjuvants to peripheral nerve block (PNB). Both have been found to delay and reduce the incidence of rebound pain (RP), prolong the duration of sensory and motor block, and enhance analgesia without causing significant respiratory depression. Few studies have explored the effectiveness of dexmedetomidine or dexamethasone as sole adjuvants to PNB for preventing or reducing RP. However, to the best of our knowledge, no study has directly compared the effectiveness of these two drugs in reducing RP when used as adjuvants to local anesthetic (LA) in PNB. Due to differences in their mechanism of action, their effects on RP may differ significantly. We hypothesized that the combination of dexamethasone and dexmedetomidine reduces the incidence of RP when used as adjuvants to LA in PNB.

Detailed Description

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Conditions

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Brachial Plexus Blocks

Keywords

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Dexamethasone dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

8 mg of dexamethasone will be added to the local anesthetic.The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Group Type ACTIVE_COMPARATOR

Group A

Intervention Type DRUG

8 mg of dexamethasone will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Group B

1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Group Type ACTIVE_COMPARATOR

Group B

Intervention Type DRUG

1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Group C

8 mg of dexamethasone + 1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Group Type ACTIVE_COMPARATOR

Group C

Intervention Type DRUG

8 mg of dexamethasone + 1 microgram/kg dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Interventions

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Group A

8 mg of dexamethasone will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Intervention Type DRUG

Group B

1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Intervention Type DRUG

Group C

8 mg of dexamethasone + 1 microgram/kg dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* from 20-65 years old
* and ASA physical status I or II and III,
* and of either gender,
* who provided informed, written, and valid consent,
* were scheduled for elective orthopedic upper limb surgeries for traumatic fractures under Supraclavicular Brachial Plexus Block.

Exclusion Criteria

* Patients with coagulopathies,
* neurological disorders,
* hypersensitivity to any of the study drugs, or
* a history of previous surgeries on the affected limb
* and those who refused to sign informed consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University, Faculty of Medicine

Banhā, Qalyubiyya, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Neveen A Kohaf, Ph.D

Role: CONTACT

Phone: +201060383012

Email: [email protected]

Facility Contacts

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Neveen A. Kohaf, PhD

Role: primary

Other Identifiers

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RC. 10.9.2025

Identifier Type: -

Identifier Source: org_study_id