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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811891872703 Date of Registration: 27/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Multifidus cervicis plane (MCP) block versus Inter-Semispinal Plane (ISP) block for cervical spine surgery
Official scientific title Feasibility and efficacy of Multifidus cervicis plane (MCP) block versus Inter-Semispinal Plane (ISP) block for postoperative analgesia following cervical spine surgery; a prospective randomized trial
Brief summary describing the background and objectives of the trial Posterior cervical spinal surgery is frequently associated with significant postoperative pain. Postoperative pain hinders early mobilization and rehabilitation and contributes to patient morbidity. 1 Many analgesic regimens have been evaluated to relieve such pain. Opioids analgesics have been documented to increase the risk of respiratory depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used as first-line treatment for acute pain after spine surgery but may provide inadequate analgesia. In addition, high doses of NSAIDs have also been implicated for nonunion in spine fusion surgeries. 2,3 The multifidus cervicis plane (MCP) block involves local anesthetic injection between the fascial plane of the multifidus cervicis and semispinalis cervicis muscles. 4 The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves local anesthetic injection into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles.5 The aim of this study is to evaluate the feasibility and efficiency of multifidus cervicis plane (MCP) block versus inter-semispinal Plane (ISP) block for postoperative analgesia in patients undergoing cervical spine surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cervical spine surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2018
Actual trial start date 03/01/2019
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
32516 Tanta University, Faculty of Medicine, Research Ethics Committee Quality Assurance Unit
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intersemispinal plane block 20 ml of 0.25% bupivacaine on each side single shot bilateral ultrasound guided ISP block after induction of general anesthesia. 20 ml of 0.25% bupivacaine will be injected on each side in the fascial plane between the semispinalis cervicis and semispinalis capitis muscles at the level of C5. 30 Active-Treatment of Control Group
Experimental Group Multifidus cervicis plane block 20 ml of 0.25% bupivacaine on each side single shot bilateral ultrasound guided CIP block after induction of general anesthesia. 20 ml of 0.25% bupivacaine will be injected on each side in the fascial plane between the multifidus cervicis and semispinalis cervicis muscles at the level of C5. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 18-60 years of either gender ASA I-II undergoing elective cervical spine surgery Patient refusal patients with any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality) known allergy to local anesthetics mental disorders drug or alcohol abuse Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),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 01/08/2018 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the block performance time defined as the interval between the first needle insertion and its removal after administration of the block. once after complete administration of the block.
Secondary Outcome number of attempts which is the number of needle punctures. once after complete administration of the block.
Secondary Outcome 24h postoperative rescue analgesic consumption once after 24 h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohamed Shebl Alfateh street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com +201270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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