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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-65
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Patients with coagulopathies,

neurological disorders,

hypersensitivity to any of the study drugs, or

a history of previous surgeries on the affected limb

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A (Dexamethasone)

    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 (Dexmedetomidine)

    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 (Dexamethasone + Dexmedetomidine)

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of rebound pain after the end of anesthesia

The incidence of rebound pain after the end of anaesthesia will be measured. Rebound pain refers to a transient, intense increase in pain that occurs after the resolution of a peripheral nerve block. It represents the patient's perception of a sudden change from numbness to severe pain once the block wears off - often within the first 24 hours postoperatively. The Visual Analogue Scale (VAS) will be used to measure pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).

Time frame
24 hours

Secondary outcomes

1

Onset of Rebound Pain

The onset of rebound pain is the time interval between the resolution of the peripheral nerve block and the patient's first report of significant pain. The Visual Analogue Scale (VAS) will be used to measure a patient's subjective pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).

Time frame
24 hours
2

Duration of Rebound Pain

The duration of rebound pain refers to the length of time the heightened pain persists after its onset until it returns to a baseline or tolerable level with analgesic management.

Time frame
24 hours
3

Severity of Rebound Pain

The severity of rebound pain is the intensity of pain experienced after block resolution, typically measured using the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) will be used to measure a patient's subjective pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).

Time frame
24 hours
4

Time to first analgesic request

The time to first request for analgeseia will be measured

Time frame
24 hours

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Benha University

Collaborator

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