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.: PACTR201811839455522 Date of Approval: 27/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Inter-semispinal plane (ISP) block
Official scientific title Inter-semispinal plane (ISP) block for postoperative analgesia following cervical spine surgery: a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Significant postoperative pain is a frequently encountered complication following posterior cervical spinal surgery. Postoperative pain delays early mobilization and rehabilitation Thus contributing to patient morbidity. 1 Many analgesic regimens have been investigated. Opioids analgesics carry the risk of respiratory depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) are 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 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.4 The aim of this study is to evaluate the analgesic efficacy of ISP 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 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 12/12/2018
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date 04/11/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
32515 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 group whole study time general anesthesia only with bilateral sham ISP block using 1 ml normal saline. 30 Placebo
Experimental Group Intersemispinal 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 semispinalis cervicis and semispinalis capitis 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 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 the 24 h postoperative rescue pethidine consumption. once after 24 h
Secondary Outcome postoperative VAS scores at admission to the PACU, 30min, 1h, 2h ,4h, 6h, 8h, 12, 18, and 24h postoperative.
Secondary Outcome intraoperative fentanyl consumption. once at the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta 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 +201120014472 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 +201120014472 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