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

NCT07299877 | Not Yet Recruiting Phase 4

• 1 other identifier: RC. 10.9.2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brachial Plexus Blocks

Keywords

Dexamethasone; dexmedetomidine

Outcome Measures

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).

  24 hours

Secondary Outcomes (8)

• Onset of Rebound Pain

  24 hours

• Duration of Rebound Pain

  24 hours

• Severity of Rebound Pain

  24 hours

• Time to first analgesic request

  24 hours

• Incidence of sleep disturbances due to surgical site pain

  48 hours

Study Arms (3)

Group A

ACTIVE COMPARATOR

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.

Drug: Group A (Dexamethasone)

Group B

ACTIVE COMPARATOR

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.

Drug: Group B (Dexmedetomidine)

Group C

ACTIVE COMPARATOR

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.

Drug: Group C (Dexamethasone + Dexmedetomidine)

Interventions

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.

Group C

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 A

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 B

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (1)

Benha University, Faculty of Medicine

Banhā, Qalyubiyya, 300001, Egypt

Location

MeSH Terms

Interventions

Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Neveen A Kohaf, Ph.D

CONTACT

+201060383012; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)