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.: PACTR202001596903715 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study of three different doses of nalbuphine as an adjuvant to bupivacaine in suprascapular nerve block for postoperative analgesia in arthroscopic shoulder surgery
Official scientific title A comparative study of three different doses of nalbuphine as an adjuvant to bupivacaine in suprascapular nerve block for postoperative analgesia in arthroscopic shoulder surgery
Brief summary describing the background and objectives of the trial the eighty patients will receive ultrasound guided suprascapular nerve block in the sitting position. Then the patients will allow to be in supine position and induction of general anesthesia after completion of surgery the patient assessed for pain severity
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial in suprascapular nerve block
Anticipated trial start date 23/12/2019
Actual trial start date 23/12/2019
Anticipated date of last follow up 08/01/2020
Actual Last follow-up date 01/04/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group suprascapular nerve block receive suprascapular nerve block with 15ml of o.5%bupivacaine only pre operatively then will receive general anesthesia. single shot receive suprascapular nerve block with 15ml of o.5%bupivacaine only pre operatively then will receive general anesthesia.after surgery the patient assessed for 24hour for pain 20 Active-Treatment of Control Group
Experimental Group suprascapular nerve block patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacine and 0.8mg nalbuphine pre operatively then the patientd will be receive general anesthesia. single shot patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacine and 0.8mg nalbuphine pre operatively then the patientd will be receive general anesthesia.after surgery patients assessed for pain severity 20
Experimental Group suprascapular nerve block patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacaine and 1.8mg nalbuphine pre operatively then will receive general anesthesia. single shot patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacaine and 1.8mg nalbuphine pre operatively then will receive general anesthesia.after surgery patients assessed for pain severity 20
Experimental Group suprascapular nerve block patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacaine and 2.4mg nalbuphine pre operatively then will be given general anesthesia single shot patients will receive ultrasound guided suprascapular nerve block with 15ml 0.5% bupivacaine and 2.4mg nalbuphine pre operatively then will be given general anesthesia after surgery patients assessed for pain severity 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I-IIl obesity , allergy to local anesthetic, coagulopathy presence of infection at the site of the block. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 22/12/2019 Ethical commiittee . department of anesthsiology . intensive care and pain manegement .faculty of medicine menofia university
Ethics Committee Address
Street address City Postal code Country
shebin elkom shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome result related to the VAS score postoperative from discharge from PACU to 24hour postoperative
Secondary Outcome : side effects (nausea and vomiting),additional analgesic requirements,and Ramsey Sedation Scores (RSS) will recorded. RSS>or= 5 will considered excessive sedation postoperative from discha-rge from PACU to 24hour postoperativ
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medecine . menofia university shebin elkom shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Noha abd allah elsayed afify shebin elkom shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university shebin elkom shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nevien mostafa soliman Alexandria Alexandria 21500 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes اقر انا اننى موافق على حقن العصب فوق الكتف من أجل تسكين الالم ما بعد الجراحة في جراحة الكتف كمكمل للتخدير العام وتم توضيح الاثار الجانبيه المتعلقه سواء بهذا الحقن اوالمواد المستخدمه وتم ايضاح هذا دون اجهام منى بذلك. المقر بما فيه Patient name: I agree to inject the suprascapular nerve block for postoperative analgesia in arthroscopic shoulder surgeryas a supplement to general anesthesia, and the side effects related to this injection or the materials used have been clarified and this has been clarified without me being tempted to do so. Signature : Study Protocol within three months controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information