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Not yet recruiting NCT07299877

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

Phase IV Interventional Brachial Plexus Blocks

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A (Dexamethasone), Group B (Dexmedetomidine), Group C (Dexamethasone + Dexmedetomidine).
Who it may be relevant to
Registry conditions: Brachial Plexus Blocks. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Perineural Dexamethasone, Dexmedetomidine or Their Combination: an Effort to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block: A Triple-Blind Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Group A (Dexamethasone)
    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.
  • Drug Group B (Dexmedetomidine)
    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.
  • Drug Group C (Dexamethasone + Dexmedetomidine)
    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.

Primary outcome measures

  • The incidence of rebound pain after the end of anesthesia [Time frame: 24 hours]
Secondary outcome measures (8)
  • Onset of Rebound Pain [Time frame: 24 hours]
  • Duration of Rebound Pain [Time frame: 24 hours]
  • Severity of Rebound Pain [Time frame: 24 hours]
  • Time to first analgesic request [Time frame: 24 hours]
  • Incidence of sleep disturbances due to surgical site pain [Time frame: 48 hours]
  • Pain score [Time frame: 24 hours]
  • Consumption of fentanyl [Time frame: 48 hours]
  • Patient satisfaction. [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Benha University, Faculty of Medicine — Banhā

Identifiers

NCT: NCT07299877 · RC. 10.9.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗