Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001879340 Date of Approval: 20/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title us guided BSCPB for thyroid surgery
Official scientific title Ultrasound guided bilateral superficial cervical plexus block for thyroid surgery :Bupivacaine versus bupivacaine dexmedetomidine.
Brief summary describing the background and objectives of the trial The superficial cervical Plexus is formed from the ventral rami of the first four cervical nerves ( C1 ¿ C4 ). It emerges from behind the posterior border of sternomastoid muscle to give sensory innervation to the anterior compartment of the neck . Branches of superficial cervical plexus include lesser occipital ( C2) , greater auricular (C 2,3 ), anterior cutaneous nerve of the neck ( C 2 ,3) and supraclavicular nerve (C 3,4) . ( Aunac et al ; 2002) (SCPB) is simple and easy to perform technique however its use as a blind technique is not always successful and its efficacy is controversial (Herbland et al; 2006) . The SCPB provides major effect on sensory roots than the motor roots which can be blocked by deep cervical plexus block. Because only the sensory nerves are anesthetized in the SCPB, one may encounter some surgical difficulty because the muscles will maintain their tone and move intraoperatively if superficial cervical plexus block is used as a sole anesthetic for thyroid surgery .( Ellis ; 2004). Blockade of the (SCPB) alone has been found adequate for thyroidectomy in some studies but with some drawbacks like coughing, postural aches, discomfort , and pain . This block was adequate to prevent pain of skin incision and tissue dissection . (Kolawol and Rahman 2003). Bilateral Deep cervical plexus block carries the risk of phrenic nerve block, which can carry a serious ventilatory hazard.(Murphy; 2014). Dexmedetomidine so that Precedex, Hospira) is a selective alpha 2adrenoceptor agonist which is used as a sedative and analgesic drug . Some studies showed that it may prolong the duration of action of local anesthetics by prolongation of sensory blockade . (Rancourt et al ; 2012). Our study hypothesis aims to evaluate effects of addition of dexmedetomidine to bupivacaine in Bilateral Superficial Cervical Plexus Block (BSCPB) on pain perception intra and postoperatively for thyroid surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nutritional, Metabolic, Endocrine,Surgery,thyroid surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2015
Actual trial start date 10/07/2015
Anticipated date of last follow up 02/07/2016
Actual Last follow-up date 02/07/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
R133 medical local ethical committee /Mansoura faculty of medicicne
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 Simple randomisation using by using procedures such as coin-tossing or dice-rolling Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group us guided BSCPB with bupivacaine bupivacaine 0 . 35% 10 ml on each side before surgery while under general anesthesia with 1/200000epinephrine single injection The BUP group( bupivacaine group) which will receive bupivacaine 0 . 35% 10 ml on each side before surgery while under general anesthesia with 1/200000epinephrine 20 Placebo
Experimental Group us guided BSCPB with bupivacaine dexmedetomidine receive dexmedetomidine 40 ug plus bupivacane¿ 0.3 10 ml on each side with 1/200000 epinephrine single injection the DEX. group (dexmedetomidine group) which will receive dexmedetomidine 40 ug plus bupivacane¿ 0.3 10 ml on each side with 1/200000 epinephrine before surgery while under general anesthesia.). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients ; ASA I and II status 2. Patients who will undergo thyroid surgery including: goiters , tumors and cysts . 3. The age group is between 25 and 65 years old. 1. Patients who refuse to share. 2. Coagulopathy. 3. Infection at the puncture site . 4. Severe hypertension or any severe systemic illness. 5. Allergy to local anesthetics. 6. The presence of pre-existing peripheral nerve neuropathies which may increase the risk for permanent nerve damage . Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 13/06/2015 Local Ethical committee Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score will be assessed for all patients immediately after surgery, then 2,4 6,12,18 and 24 hours after surgery using visual analogue scale and numerical pain scor immediately after surgery, then 2, 4 6, 12, 18 and 24 hours after surgery
Secondary Outcome Hemodynamics which will include mean blood pressure, heart rate and oxygen saturation will be studied during surgery every 15 minutes, Then 30 minutes and 2 hours after surgery which will include mean blood pressure, heart rate and oxygen saturation will be studied during surgery every 15 minutes , Then 30 minutes and 2 hours after surgery
Secondary Outcome Moreover the time of 1st opioid requirement on 1st opioid requesting
Secondary Outcome side effects will be recorded including hematoma , nausea , vomiting or nerve injury . any time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansourah oncology center , Mansourah university . Elgmhoria street ElMansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansourah oncology center Elgmhoria street ElMansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansourah oncology center Elgmhoria street ElMansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
alaa adel elmaadawy Elgmhoria street ElMansourah 35516 Egypt
alaa eldin mazy abdou Elgmhoria street ElMansourah 35516 Egypt
Ahmed Elsayed Lotfy Elgmhoria street ElMansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alaa elmaadawy a_maadawy@hotmail.com 00201153304999 Elgmhoria street
City Postal code Country Position/Affiliation
elmansourah 35516 Egypt lecturer in anesthesia , pain managment
Role Name Email Phone Street address
Public Enquiries alaa elmaadawy a_maadawy@hotmail.com 00201153304999 Elgmhoria street
City Postal code Country Position/Affiliation
elmansourah 35516 Egypt lecturer in anesthesia , pain managment
Role Name Email Phone Street address
Scientific Enquiries alaa eldin Mazy alaa_mazy@yahoo.com 00201140065052 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansourah 35516 Egypt Associate professor of anesthesia and pain management
REPORTING
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