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.: PACTR201703001946101 Date of Approval: 29/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and Opioid Sparing Effect of Bilateral Superficial Cervical Plexus Block for Thyroid Surgery at Gondar Hospital, North West Ethiopia
Official scientific title Efficacy and Opioid Sparing Effect of Bilateral Superficial Cervical Plexus Block for Thyroid Surgery at Gondar Hospital, North West Ethiopia
Brief summary describing the background and objectives of the trial introduction : Globally different techniques have been used to prevent intraoperative and postoperative thyroidectomy pain.These are local anesthetic infiltration subcutaneously prior to incision, regular paracetamol, non-steroidal anti-inflammatories plus weak opioids, MMA and regional techniques like superficial cervical plexus block Though SCPB is widely practiced its analgesic efficacy, role in decreas in go pioid consumption results in controversy. Pain during thyroidectomy is a common phenomenon which results release of stress hormone during surgery. The main Goals Of postoperative Pain management are to Improve quality of life for the patient; reduce morbidity; facilitaterapid recovery and return to full function and at last allow early discharge from hospital.Now a days the use of bilateral superficial cervical plexus block as multimodal analgesia became a popular technique for patients undergoing thyroidectomy. Bupivacaine is an amide local anesthetic which is metabolized by liver.And bilateral superficial cervical plexus block with 20 ml of 0.25% bupivacaine decreased complication associated with the use of systemic analgesic drug. objective : assessing the efficacy and opioid sparing effect of BSCPB for post thyroidectomy pain with 0.25% bupivacaine only among patients who came for thyroidectomy at the University of Gondar Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Surgery,thyroidectomy ,goiter,pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2017
Actual trial start date 10/01/2017
Anticipated date of last follow up 14/02/2017
Actual Last follow-up date 20/01/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using coin tosse coin tossing Open-label(Masking Not Used) Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Block group 20ml of 0.25%bupivacaine 24 hours 2o ml of 0.25% bupivacaine for superficial cervical plexus block to prevent pain and know th effeicacy of opioid sparing effects. 25 Active-Treatment of Control Group
Control Group control group(CG) nothing /block was not done 24 hours 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All available patients who are going to undergone thyroidectomy that are candidate for bilateral superficial cervical plexus block at Gondar University Hospital Operating Room Theatre who are ASA 1 and ASA II. All patients who refuse to participate age less than 18 year patients allergic for Local anesthetics patients with retrosternal goiter reoperation patients with coagulation abnormality and patients who received preoperative medications. 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 29/11/2016 Yonas addisu
Ethics Committee Address
Street address City Postal code Country
Atse bekafa gondar 196 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/01/2017 Alemayehu desalegn
Ethics Committee Address
Street address City Postal code Country
atse fasil Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare post operative pain severity between the two groups using the NRS. NRS at immediate post op at 2 hour at 6 hour at 12 hours at 245 hours
Secondary Outcome to compare opioids sparing effects between the groups tramadol consumption during post op period at 2 ,4,6,8,12,24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gondar University Hospital Atse Bekafa Gondar 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
college of Medicine and health scienece Atse Bekafa Gondar 196 Ethiopia
University of gondar Maraki Gondar 196 Ethiopia
departement of anaesthesiology and critical care Atse Bekafa Gondar 196 Ethiopia
Gondar university hospital Atse Bekafa Gondar 196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor departement of anaesthesiology and critical care Atse Bekafa Gondar 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
University of gondar Maraki Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amare Hailekiros amaretom22@gmail.com +251-9-12-86-21-44 Atse Bekafa
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia lecturer ,head of departement
Role Name Email Phone Street address
Public Enquiries Yilkal Tadesse yilkaltadesse@yahoo.com +251-9-18-72-78-06 Atse bekafa
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Girmay Lema girmaytg@yahoo.com +251-9-12-86-21-44 Atse bekafa
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Lecturer
REPORTING
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