Trial no.:	PACTR201711002773620	Date of Approval:	16/11/2017
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Comparison Between Facilitatory Effects Of Perineural Dexmedetomidine , Dexamethasone Or Lornoxicam Added To Bupivacaine And Bupivacain

Official scientific title

Comparison Between Facilitatory Effects Of Perineural Dexmedetomidine , Dexamethasone Or Lornoxicam Added To Bupivacaine And Bupivacaine Alone In Supraclavicular Brachial Plexus Block

Brief summary describing the background and objectives of the trial

The aim of this study is to evaluate the effect of adding dexmedetomidine , dexamethasone or lornoxicam as an adjuvant to bupivacaine in supra clavicular brachial plexus block on the onset time and the duration of sensory and motor blocks and duration of analgesia and side effects such as hypotension ,bradycardia, nausea, vomiting, and hypoxemia.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

elective fractures of hand forearm or elbow

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

01/06/2016

Actual trial start date

01/06/2016

Anticipated date of last follow up

29/06/2017

Actual Last follow-up date

29/06/2017

Anticipated target sample size (number of participants)

112

Actual target sample size (number of participants)

112

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	opaque sealed envelope	opaque sealed envelope	Masking/blinding used	Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Group I (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny	Group I (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml dexamethasone phosphate (8 mg) {Dexamethasone, MUP com	Group I (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml dexamethasone phosphate (8 mg) {Dexamethasone, MUP com	Group I (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml dexamethasone phosphate (8 mg) {Dexamethasone, MUP company}	28
Experimental Group	Group II (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunn	Group II (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 9 ml normal saline + 1 ml dexmedetomidine (100 mcg){ Precedex , Hospira com	Group II (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 9 ml normal saline + 1 ml dexmedetomidine (100 mcg){ Precedex , Hospira com	Group II (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 9 ml normal saline + 1 ml dexmedetomidine (100 mcg){ Precedex , Hospira company }) .	28
Experimental Group	Group III (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sun	Group III (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml loronoxicam (8 mg ) { Xefo , Multi-Apex company }) .	Group III (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml loronoxicam (8 mg ) { Xefo , Multi-Apex company }) .	Group III (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 8 ml normal saline + 2 ml loronoxicam (8 mg ) { Xefo , Multi-Apex company }) .	28
Control Group	Group IV (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunn	Group IV (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 10 ml normal saline ) as a control group .	Group IV (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 10 ml normal saline ) as a control group .	Group IV (n=28): will receive total volume 30 ml ( 20 ml bupivacaine Hcl 0.5 % {sunnypivacaine, sunny medical company} + 10 ml normal saline ) as a control group .	28	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
co-operative ASA physical status I & II patients of both sex aged 18-60 years undergoing elective surgery of hand, forearm or elbow.	1- patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal, hepatic disease; alcoholism or drug abuse; pregnancy or lactating women. 2- patients receiving adrenoceptor antagonist therapy (e.g hypertensive patients ) or chronic analgesic therapy. 3- patients with morbid obesity, uncontrolled diabetes, peripheral vascular disease. 4- suspected coagulopathy, or known allergies to any of the drugs used.		18 Year(s)	60 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

27/12/2016

fm-bsurec

Ethics Committee Address
Street address	City	Postal code	Country
Beni-Suef governerate	Beni-Suef governerate	11391	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Sensory block	every 2 min till their onset and then every 30 minute (after surgery), until they will resolved
Primary Outcome	Motor block	will assessed every 2 min till their onset and then every 30 minute (after surgery), until they will resolved

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Beni-Suef University hospital	Beni-Suef	Beni-Suef		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
no

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mohamed Abdelbadie Ali Hasanin	Beni-Suef	Beni-Suef	11391	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
Mohamed Abdelbadie Ali Hasanin	Beni-Suef	Beni-Suef	11391	Egypt
Hatem Elmoutaz	Beni-Suef	Beni-Suef	11391	Egypt
Hazem Abdelwahab Hussein	Beni-Suef	Beni-Suef	11391	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Mohamed Hasanin	doaa_rashwan@hotmail.com	01011270763	Beni Suef
City	Postal code	Country	Position/Affiliation
Beni Suef	11391	Egypt
Role	Name	Email	Phone	Street address
Public Enquiries	Mohamed Hasanin	doaa_rashwan@hotmail.com	01011270763	Beni Suef
City	Postal code	Country	Position/Affiliation
Beni Suef	11391	Egypt	M.B.B.Ch., M.Sc., of Anesthesiology , Beni Suef University
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Hasanin	doaa_rashwan@hotmail.com	01011270763	Beni Suef
City	Postal code	Country	Position/Affiliation
Beni Suef	11391	Egypt	M.B.B.Ch., M.Sc., of Anesthesiology , Beni Suef University

REPORTING
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Result URL Hyperlinks

Changes to trial information

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