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.: PACTR201811665246016 Date of Approval: 26/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cervical Interfascial Plane (CIP) block
Official scientific title Cervical Interfascial Plane (CIP) block for postoperative analgesia following cervical spine surgery: a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Patients who undergo posterior cervical spinal surgery frequently experience significant postoperative pain. Postoperative pain contributes to patient morbidity because of decreasing early voluntary mobilization and delayed rehabilitation. 1 Opioids are ideal analgesics but carry the risk of respiratory depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) are very popular as first-line treatment for acute pain after spine surgery but may provide inadequate analgesia. High doses of NSAIDs have also been implicated for nonunion in spine fusion surgeries. 2,3 The cervical interfascial plane (CIP) block involves local anesthetic injection between the multifidus and longissimus muscles at the level of C5, achieving C2-6 analgesic effect. 4 The aim of this study is to evaluate the analgesic efficacy of CIP block 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 analgesia for 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 05/01/2019
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
32517 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 control whole study time general anesthesia only with bilateral sham CIP block using 1 ml normal saline. 30 Placebo
Experimental Group Cervical Interfascial Plane block 20 ml of 0.25% bupivacaine on each side single shot 20 ml of 0.25% bupivacaine will be injected on each side in the fascial plane between the multifidus and longissimus muscle 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 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-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 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 VAS at 2h postoperative admission to the PACU, 30min, 1h, 2h ,4h, 6h, 8h, 12, 18, and 24h postoperative
Secondary Outcome intraoperative fentanyl consumption once after the end of surgery
Secondary Outcome postoperative rescue pethidine consumption. once after 24 h
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
departmental resources of 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 31511 Egypt University
Secondary Sponsor Department of anesthesia surgical ICU Algeish street Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta 31511 Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk shaimaafarouk7777@yahoo.com +201270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Tanta University Faculty of Medicine
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 Tanta University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Tanta University Faculty of Medicine
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