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

A

Al-Azhar University

Status and phase

Not yet enrolling
Phase 4

Conditions

Brachial Plexus Blocks

Treatments

Drug: Group B (Dexmedetomidine)
Drug: Group A (Dexamethasone)
Drug: Group C (Dexamethasone + Dexmedetomidine)

Study type

Interventional

Funder types

Other

Identifiers

NCT07299877
RC. 10.9.2025

Details and patient eligibility

About

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, 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. The investigators hypothesized that the combination of dexamethasone and dexmedetomidine reduces the incidence of RP when used as adjuvants to LA in PNB.

Enrollment

75 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups

Group A
Active Comparator group
Description:
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.
Treatment:
Drug: Group A (Dexamethasone)
Group B
Active Comparator group
Description:
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.
Treatment:
Drug: Group B (Dexmedetomidine)
Group C
Active Comparator group
Description:
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.
Treatment:
Drug: Group C (Dexamethasone + Dexmedetomidine)

Trial contacts and locations

1

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Central trial contact

Neveen A Kohaf, Ph.D

Data sourced from clinicaltrials.gov

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