Comparative Factorial Study Design of Ultrasound Guided Wrist Block for Hand Surgery Comparing Effect of Bupivacane Alone and Bupivacane with Dexamethasone and Bupivacane with Dexametmiodine and Bupivacane with Dexamethasone and Dexametmiodine

March 21, 2025 updated by: Mahmoud Rafaat Mohamed

A Comparative Factorial Study Design of Adjuvant Enhanced Ultrasound-Guided Wrist Block Anaesthesia for Hand Surgery : Bupivacane, Dexamethasone, Dexametmiodine

Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexametmiodine and dexamethasone.

Taking medical and surgical history from patients. Taking base line data as heart rate and blood pressure and spo2. Measure duration of analgesia for post operative pain using NRS for 24 hours abd recording NRS at time interval of 2 , 4,6,12,24 hours post operative.

Any patient the NRS above 4 will receive 5 mg nalbufin . Recording patients satisfaction by a survey .

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Aswan, Egypt
        • Recruiting
        • Aswan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Patients more than or equal 18 years old and are ASA 1-3

Exclusion Criteria:

  • allergy to used medication
  • pre exist neuropathy
  • coagulapthy
  • cognitive impairment
  • refusal to participate
  • Failed block and requiring general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: ultrasound guided wrist block with bupivacane alone
Group 1: ultrasound guided wrist block with bupivacane.025% .. 15 ml volume totally
Procedure: Group 1: ultrasound guided wrist block with bupivacane alone
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Active Comparator: Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone
Group 2: 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone
Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Active Comparator: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine
Group 3: 40 patients receive ultrasound guided wrist block with 15 ml volume totally including bupivacane.25% and 50 mcg dexametmiodine
Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
Active Comparator: Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone
Group 4 : 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone and 50 mcg dexametmiodine
Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine
Group 4 patients will receive ultrasound guided wrist block with bupivacan.25%e and 8 mg dexamethasone and 50 mcg dexametmiodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the effectiveness of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine
Time Frame: 24 hour
Comparing duration of analgesia by each combination from block administration to first request of analgesia
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Rafaat Mohamed

Investigators

  • Study Director: Zaher Zaki Zaher, Specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Estimated)

August 7, 2025

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 963-9-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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