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.: PACTR202008687031377 Date of Approval: 11/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Suprazygomatic maxillary nerve block in septorhinoplasty.
Official scientific title Efficacy of ultrasound-guided suprazygomatic maxillary nerve block on emergence agitation and postoperative analgesia after septorhinoplasty. A prospective randomized trial
Brief summary describing the background and objectives of the trial Application of a multimodal approach for analgesia with systemic agents and regional nerve block techniques has been advocated for managing pain in septorhinoplasty when feasible. The preemptive analgesia produced by peripheral nerve blocks employed with general anesthesia has the advantage of providing a stable hemodynamic profile, good quality of recovery besides a reduction in both intra and postoperative analgesic requirements. In this study we will test the hypothesis that bilateral application of ultrasound-guided suprazygomatic maxillary nerve block could decrease the incidence of emergence agitation as a primary outcome, along with reduction in postoperative pain scores and total analgesic requirements as secondary outcomes in adult patients undergoing septorhinoplasty.
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 Treatment: Other
Anticipated trial start date 20/07/2020
Actual trial start date
Anticipated date of last follow up 15/12/2020
Actual Last follow-up date
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
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 General anesthesia Group I once once patients in group I will receive general anesthesia alone 30 Placebo
Experimental Group suprazygomatic maxillary nerve block once once Patients in group II will receive general anesthesia combined with bilateral ultrasound- guided suprazygomatic maxillary nerve block .A linear ultrasound transducer (5-13 MHz) is positioned in the infrazygomatic region. the needle will be introduced in a perpendicular orientation at the angle between the posterior orbital rim and the upper margin of the zygomatic arch to reach the pterygopalatine fossa and 5 mL of 0.25% bupivacaine is injected after a negative aspiration of blood is confirmed. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty patients aged 18-60 years of both gender classified by the American Society of Anesthesiologists as ASA I-II scheduled for elective septorhinoplasty surgery under general anesthesia patient's refusal body mass index >35 kg/m2 pre-existing neurological disease infection at site of the block coagulopathy allergy to local anesthetics chronic analgesic use inability to express NRS score. 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 01/06/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
Elgeish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of emergence agitation once
Secondary Outcome postoperative pain and total postoperative analgesic consumption pain scores within 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University Elgeish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Elgeish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona El Mourad Elgeish Tanta 31527 Egypt
Mohamed Afandy Elgeish Tanta 31527 Egypt
Tarek gamal shoukr Elgeish Tanta 31527 Egypt
Mohamed Samir Abd Elghafar Elgeish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of anesthesia Faculty of Medicine Tanta university
Role Name Email Phone Street address
Public Enquiries Mona El Mourad monamorad80@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor of Anesthesia Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Afandy mohamedafandy811@yahoo.com 00201225131526 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data, the incidence of emergence agitation, and postoperative analgesic consumption Study Protocol 2 years to those who request the data via the email of the principal investigator according to the cause of the request
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