Trial no.:	PACTR201709002537314	Date of Approval:	22/08/2017
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Intra-articular morphine versus dexmedetomedine for knee arthroscopy

Official scientific title

Intra-articular morphine versus dexmedetomedine for knee arthroscopy under local anesthesia.

Brief summary describing the background and objectives of the trial

One of the most common and important orthopedic procedures is knee arthroscopy; It has both diagnostic and therapeutic applications. Knee arthroscopy has become the gold standard for diagnosis and management of meniscal and ligamentous injuries [Bohensky et al ; 2012]. General, regional or local anesthesia could be performed for knee arthroscopy. However, to provide faster discharge times, epidural anesthesia and peripheral nerve block have both provided more rapid discharge than general anesthesia .Moreover , spinal anesthesia has rapid discharge compared to general anesthesia. [Mulroy et al ; 2000]. The use of local anaesthesia started over the past few decades [Takahashi et al 2004] but still considered inferior to other forms of anesthesia , owing to the fear of insufficient anesthesia or because of a bad patient experience [Al-Qtaibi 2013]. In fact it prevents any pain sensation during knee surgery, the patient is conscious throughout the procedure and discharged soon [Shaukat et al 2013]. It also gives the advantages of post-operative analgesia, increased blood flow to extremities, theoretical decrease in reflex sympathetic dystrophy, decreased the common side effects of analgesics as nausea , vomiting, drowsiness and urinary retention [Maldini et al; 2010]. Dexmedetomedine is a potent and highly selective ¿2 adrenoceptor agonist which also has a sympatholytic, sedative, amnestic, and analgesic properties [Coursin et al ; 2001]. The mechanism by which Dexmedetomedine mediates intra-articular analgesia is not clearly defined. However, it might be similar to those suggested for intra-articular clonidine [Afonso et al 2012]. Clonidine may act on ¿2-adrenergic presynaptic receptors and inhibit the release of norepinephrine at peripheral afferent nociceptors. It can provide local anaesthetic effects by inhibiting the conduction of nerve signals .

Type of trial

RCT

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

Disease(s) or condition(s) being studied

Injury, Occupational Diseases, Poisoning,knee arthroscopy,Surgery

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

Purpose of the trial

Treatment: Surgery

Anticipated trial start date

10/07/2016

Actual trial start date

10/07/2016

Anticipated date of last follow up

01/11/2017

Actual Last follow-up date

21/08/2017

Anticipated target sample size (number of participants)

51

Actual target sample size (number of participants)

60

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register
Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura University.	Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura Uni
Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura University.	Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura Uni

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
Crossover: all participants receive all interventions in different sequence during study	Randomised	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study	Randomised	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Group M: Morphine group	) patients will receive a volume 20 ml of 0.5% bupivacaine plus 5 ml of 0.2% lidocaine with epinephrine 1:200,000 plus 1 mg morphine.	single shot	) patients will receive a volume 20 ml of 0.5% bupivacaine plus 5 ml of 0.2% lidocaine with epinephrine 1:200,000 plus 1 mg morphine.	30	Active-Treatment of Control Group
Experimental Group	Group D: dexmedetomedine group	patients will receive a volume 20 ml of 0.5% bupivacaine plus 5 ml of 0.2% lidocaine with epinephrine 1:200,000 plus 1 ¿g/kg dexmedetomedine .	single shot	patients will receive a volume 20 ml of 0.5% bupivacaine plus 5 ml of 0.2% lidocaine with epinephrine 1:200,000 plus 1 ¿g/kg dexmedetomedine .	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
patients Submitted for elective knee arthroscopy who: ¿ Age ranging from (25- 45) years. ¿ Of either sex. ¿ (ASA) I and II.	¿ Refusal of the patient. ¿ They have an allergy to the used drugs. ¿ Langue or Psychological problems. ¿ Any previous surgery to the knee. ¿ Patients with chronic extensive synovitis. ¿ Patients on chronic pain medications . ¿ Infection at the portal sites of injection. ¿ Bleeding diathesis or coagulopathy.		25 Year(s)	45 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

03/07/2016

IRB Mansoura faculty of medicine

Ethics Committee Address
Street address	City	Postal code	Country
Elgmhoria street Egypt	elmansoura	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	post operative VAS	at 1, 2, 4, 6, 12, and 24 h,
Secondary Outcome	¿ Total analgesic need and the onset of first intravenous analgesia	post operatively
Secondary Outcome	¿ Surgeon satisfaction score	after 24 h
Secondary Outcome	post-operative side effects or complications	post operatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Mansoura University Hospitals	Elgmhoria street Egypt	Elmansourah	35516	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Mansoura University hospitals Egypt	Elgmhoria street Egypt	Elmansourah	35516	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansoura University hospitals	Elgmhoria street	Elmansourah	35516	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
Alaa Elmadawy	Elgmhoria street Egypt	Elmansourah	35516	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Alaa Elmaddawy	a_maadawy@hotmail.com	00201153304999	Elgmhoria street
City	Postal code	Country	Position/Affiliation
Elmansourah	35516	Egypt	lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Alaa elmaddawy	aaae72@gmail.com	00201153304999	Elgomhoria street, Anesthesia department,mansoura university hospitals.
City	Postal code	Country	Position/Affiliation
elmansourah	35516	Egypt	Lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Alaa elmaddawy	aaae72@gmail.com	00201153304999	Elgomhoria street, Anesthesia department,mansoura university hospitals.
City	Postal code	Country	Position/Affiliation
elmansourah	35516	Egypt	Lecturer

REPORTING
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Changes to trial information

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