- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826690
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
A Comparative Factorial Study Design of Adjuvant Enhanced Ultrasound-Guided Wrist Block Anaesthesia for Hand Surgery : Bupivacane, Dexamethasone, Dexametmiodine
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Group 1: ultrasound guided wrist block with bupivacane alone
- Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone
- Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine
- Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Aswan Governorate
-
Aswān, Aswan Governorate, Egypt
- Aswan university hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
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
|
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
Group 4 patients will receive ultrasound guided wrist block with bupivacan.25%e
and 8 mg dexamethasone and 50 mcg dexametmiodine
|
|
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
|
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
Group 4 patients will receive ultrasound guided wrist block with bupivacan.25%e
and 8 mg dexamethasone and 50 mcg dexametmiodine
|
|
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
|
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
Group 4 patients will receive ultrasound guided wrist block with bupivacan.25%e
and 8 mg dexamethasone and 50 mcg dexametmiodine
|
|
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
|
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
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 |
|---|---|---|
|
dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia, defined as the time from completion of the block to the first request for rescue analgesia.
Time Frame: defined as the time from block administration to first request of analgesia during the first 24 hour
|
defined as the time from block administration to first request of analgesia
|
defined as the time from block administration to first request of analgesia during the first 24 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zaher Zaki Zaher, Specialist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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