NCT07074691

Brief Summary

This study aimed to compare the effect of regional and intravenous Dexamethasone in the prophylaxis of rebound pain after supraclavicular block in upper limb surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

July 10, 2025

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the first request of analgesia

    Time to the first request of analgesia was recorded from the end of surgery till the first dose of pethidine administrated.

    24 hours postoperatively

Secondary Outcomes (4)

  • Degree of pain

    24 hours postoperatively

  • Patient Satisfaction

    24 hours postoperatively

  • Total Analgesics consumption

    24 hours postoperatively

  • Incidence of complications

    24 hours postoperatively

Study Arms (2)

Regional Dexamethasone group

EXPERIMENTAL

Patients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone).

Drug: Regional Dexamethasone

Intravenous Dexamethasone group

EXPERIMENTAL

Patients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline).

Drug: Intravenous Dexamethasone

Interventions

Patients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone).

Regional Dexamethasone group

Patients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline).

Intravenous Dexamethasone group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 21 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) class I-II.
  • Undergoing upper limb surgeries.

You may not qualify if:

  • Patient refusal.
  • History of allergy to drugs used.
  • ASA class more than II ( III-IV-..).
  • Uncooperative patient.
  • Patients on chronic pain medications.
  • Coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

March 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations