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NCT Number: NCT07299877

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

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.

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Key information

Conditions

Brachial Plexus Blocks

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha University, Faculty of Medicine

Banhā, Qalyubiyya, 300001, Egypt

Location contact

Hany Baumy, M.D

PRINCIPAL_INVESTIGATOR

Neveen A. Kohaf, PhD

CONTACT

[email protected]

01060383012

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of rebound pain after the end of anesthesia

    Time frame: 24 hours

    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).

Secondary outcomes

  1. Onset of Rebound Pain

    Time frame: 24 hours

    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).

  2. Duration of Rebound Pain

    Time frame: 24 hours

    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.

  3. Severity of Rebound Pain

    Time frame: 24 hours

    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).

  4. Time to first analgesic request

    Time frame: 24 hours

    The time to first request for analgeseia will be measured

  5. Incidence of sleep disturbances due to surgical site pain

    Time frame: 48 hours

    Sleep disturbance due to surgical site pain refers to difficulty initiating or maintaining sleep, or poor sleep quality, directly attributed to postoperative pain from the surgical site during the recovery period (usually within the first few nights after surgery).

    Assessment Method Direct Patient Questioning

    A structured interview asking:

    "Did pain at your surgical site interfere with your sleep last night?" "How many times did you wake up because of pain?" "How would you rate your sleep quality (excellent, good, fair, poor)?" A "yes" or poor sleep rating indicates sleep disturbance.

  6. Pain score

    Time frame: 24 hours

    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).

  7. Consumption of fentanyl

    Time frame: 48 hours

    the amount of of fentanyl rescue analgesia within the first 48 hours after surgery will be documented.

  8. Patient satisfaction.

    Time frame: 24 hours

    Simple, structured questions will be used postoperatively:

    "How satisfied are you with your anaesthesia care?" "Were you comfortable during and after surgery?"

    Responses are rated on a Likert scale, such as:

    1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.

    This allows calculation of the percentage of satisfied patients (scores 4-5).

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A Kohaf, Ph.D

CONTACT

[email protected]

+201060383012

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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