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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Brachial Plexus Blocks
• Intervention / Treatment: Drug: Group A (Dexamethasone); Drug: Group B (Dexmedetomidine); Drug: Group C (Dexamethasone + Dexmedetomidine)

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neveen A Kohaf, Ph.D; Phone Number: +201060383012; Email: nevenabdo@azhar.edu.eg

Study Locations

• Egypt
  • Qalyubiyya
    • Banhā, Qalyubiyya, Egypt, 300001
      • Benha University, Faculty of Medicine
      • Contact: Neveen A. Kohaf, PhD; Phone Number: 01060383012; Email: nevenabdo@azhar.edu.eg
      • Principal Investigator: Hany Baumy, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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); 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.
Active Comparator: Group B; 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); 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.
Active Comparator: Group C; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours
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.	24 hours
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).	24 hours
Time to first analgesic request	The time to first request for analgeseia will be measured	24 hours
Incidence of sleep disturbances due to surgical site pain	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.	48 hours
Pain score	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).	24 hours
Consumption of fentanyl	the amount of of fentanyl rescue analgesia within the first 48 hours after surgery will be documented.	48 hours
Patient satisfaction.	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).	24 hours

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: dexmedetomidine; Dexamethasone
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Polycyclic Compounds; Imidazoles; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; Dexmedetomidine
• Other Study ID Numbers: RC. 10.9.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data could be shared with a reasonable request from corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No