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.: PACTR202001840074546 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided lumbar erector spinae plane block as a Supplement to General Anesthesia for postoperative pain management in orthopedic surgery: A Comparison Between different Drug Combinations.
Official scientific title Ultrasound Guided lumbar erector spinae plane block as a Supplement to General Anesthesia for postoperative pain management in orthopedic surgery: A Comparison Between different Drug Combinations.
Brief summary describing the background and objectives of the trial The erector spinae plane (ESP) block is a novel ultrasound-guided regional anesthetic technique described in 2016 by Forero and colleagues. The ESP block belongs to the family of fascial plane blocks in which local anesthetic is injected into a plane between two layers of fascia and subsequently spreads to nerves located within that plane or within adjacent tissue compartments.We conduct this study to compare the analgesic efficiency of fentanyle, dexmedetomidine and magnesium sulfate as a adjuvant to bupivacaine in lumber erector spine plane block for orthopedic surgery.
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 compare analgesic effeciency of diffrent drug combination injected in erector spinea plane block in orthopedic surgery
Anticipated trial start date 23/12/2019
Actual trial start date 23/12/2019
Anticipated date of last follow up 04/01/2020
Actual Last follow-up date 30/04/2020
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 erector spinae block patients received ultrasound guided ESPB using 20ml of bupivacaine 0.5% + 20ml normal saline single shot patients received ultrasound guided ESPB using 20ml of bupivacaine 0.5% + 20ml normal saline Postoperatively, all patients were scheduled for analgesics ( paracetamol ,ketorolac and nalbuphen). The patients were evaluated for pain scores 20 Active-Treatment of Control Group
Experimental Group erector spinae block patients received ultrasound guided ESPB using 20ml bupivacaine 0.5% + 18 ml normal saline + 100 mcg fentanyl (2 ml). single shot patients received ultrasound guided ESPB using 20ml bupivacaine 0.5% + 18 ml normal saline + 100 mcg fentanyl (2 ml).all patients were scheduled for analgesics ( paracetamol ,ketorolac and nalbuphen). The patients were evaluated for pain scores 20
Experimental Group erector spinae block patients received ultrasound guided ESPB using 20ml bupivacaine 0.5%+ 18 ml normal saline +1 µg/kg dexmedetomidine ( 2 mL) . single shot patients received ultrasound guided ESPB using 20ml bupivacaine 0.5%+ 18 ml normal saline +1 µg/kg dexmedetomidine ( 2 mL) . all patients were scheduled for analgesics ( paracetamol ,ketorolac and nalbuphen). The patients were evaluated for pain scores 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Anesthesiologists physical status class I, II, III undergoing elective surgeries performed under general anesthesia with spine deformity, infection at the block site, drug allergy, renal disease coagulation disorders Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 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 the amount of analgesics used in the first 24 postoperative hours. postoperative from discha-rge from PACU to 24hour postoperativ
Secondary Outcome intraoperative fentanyle consumption, time to the first call for analgesia starting from the administration of the ESPB block till the patient asks for analgesia postoperatively. The severity of both nausea and sedation was assessed by patients on a 4-point scale (none, mild, moderate, and severe). all the patients were also evaluated for any complications starting from the administration of the ESPB block till 24 hour postoperative
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 الكتلة العصبيه القطنية حول العضله الناصبه للعمود الفقرى كمكمل للتخدير الكلى لتسكين ألام بعد العملية الجراحية في جراحة العظام 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 erector spinea plane blockfor 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information