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.: PACTR202002695592368 Date of Approval: 07/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sequential Intrathecal injection of hyperbaric and isobaric bupivecaine in orhtogeriatric lower limb surgery
Official scientific title Sequential Intrathecal injection of hyperbaric and isobaric bupivecaine in orhtogeriatric lower limb surgery
Brief summary describing the background and objectives of the trial Hip fracture is the most common type of fracture in the elderly population. Regional anesthesia has been preferred by anesthesiologists due to better analgesic profile lower incidence of complications like delirium, and thromboembolic events, added to the simplicity of the technique. However, the risk of hypotension by rapid onset of sympathetic blockade under such dense spinal anesthesia remains a major concern(Atallah & Abdel Dayem, 2015; Kowark, Rossaint, & Coburn, 2019). The major factors in determining the spread of local anesthetics in cerebrospinal fluid (CSF) are the dose of local anesthetic, the baricity of the solution and subsequent posture of the patient(Atashkhoei, Abedini, Pourfathi, Znoz, & Marandi, 2017; Gupta et al., 2013; Uppal, Retter, Shanthanna, Prabhakar, & McKeen, 2017).. Providing dose and position are constant, the baricity of the local anesthetic solution is the major factor in determining spread of spinal anesthesia. While isobaric solutions, especially in small doses, have limited spread, hyperbaric solutions extend through CSF under the influence of gravity to the lowest level of the vertebral column(Desai, Lim, Tan, & Sia, 2010; Helmi, Uyun, Suwondo, & Widodo, 2014; Sng et al., 2018). To reduce or eliminate some disadvantages of hyperbaric and isobaric spinal anesthesia, while preserving advantages of both, we studied sequential administration of the same dose of isobaric and hyperbaric bupivacaine. We proposed the sequential subarachnoid injection of low doses of plain and hyperbaric bupivacaine. Therefore, low dose plain bupivacaine could be used to obtain dense anesthesia for the surgical site, followed by low dose hyperbaric bupivacaine to achieve less dense anesthesia, thus the sympathetic function could be partially spared, whilst providing satisfactory anesthesia with cardiovascular stability. The primary outcome will be the decrease in the incidence of arterial hypotension. Secondary outcomes will include use of vasopressors, surgery feasibility and duration of sensory block, and perioperative complications including nausea, vomiting, shivering, and delirium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/02/2020
Actual trial start date 08/02/2020
Anticipated date of last follow up 08/05/2020
Actual Last follow-up date 15/06/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group HB 2 ml hyperbaric bupivecaine 0.5% will be used for Intrathecal anesthesia during the surgery (2-3 hours) and the first postoperative day With the patient in the sitting position, dural puncture will be performed at L4-5 interspace using a midline approach with a 25- gauge Quincke point needle with its bevel initially oriented laterally. After free flow of CSF, in group HB 3 mL of 0.5% hyperbaric bupivacaine mixed with 15 µ of fentanyl citrate will be administered over 20 s without barbotage. After withdrawing the spinal needle, all patients will be immediately positioned 25 Active-Treatment of Control Group
Experimental Group group HIB 1.5 mL of 0.5% plain bupivacaine will be injected, followed immediately by 1.5 mL of 0.5% hyperbaric bupivacaine mixed with 15 µ of fentanyl citrate during the surgery (2-3 hours ) and the first post-operative day With the patient in the sitting position, dural puncture will be performed at L4-5 interspace using a midline approach with a 25- gauge Quincke point needle with its bevel initially oriented laterally. After free flow of CSF, In group HIB, 1.5 mL of 0.5% plain bupivacaine will be injected, followed immediately by 1.5 mL of 0.5% hyperbaric bupivacaine mixed with 15 µ of fentanyl citrate . Each sequential injection will be given over 10 s without barbotage. After withdrawing the spinal needle, all patients will be immediately positioned 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
elderly patients (age above 60) scheduled for orthopedic lower limb surgery Patients with contraindication to spinal anesthesia (thrombocytopenia (less than 100), INR more than 1.5, valvular stenotic lesions), refusing enrollment will be excluded from the study 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 100 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 27/01/2020 Institutional review board Mansoura university
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of arterial hypotension during the surgery 2-3 hours
Secondary Outcome the intraoperative use of vasopressors during the surgery 2-3 hours
Secondary Outcome duration of sensory block 6 hours after injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MAnsoura university Emergency hospital Gihan street MAnsoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Alrefaey Masaken elobour MAnsoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sherin Bakry Ematafy styreet Masnoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +001064203475 Msaken elobour
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +20106420375 Msaken elobour
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Msaken elobour
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study results tables and protocol will be available upon request Clinical Study Report,Study Protocol 6 month after last study completion study results tables and protocol will be available upon request by researchers controlled by a third party ethical committee or IRb
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