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.: PACTR202003734769032 Date of Registration: 17/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nerve block in functional endoscopic sinus surgery
Official scientific title Nerve block using local anesthetic and dexmedetomidine in patients undergoing functional endoscopic sinus surgery
Brief summary describing the background and objectives of the trial Functional endoscopic sinus surgery (FESS) is the minimally invasive surgical method for the treatment of sinus pathology. Bleeding is one of the most serious problems of FESS. Bleeding obscure the surgical field lead to decrease quality of intervention, increase duration of surgery and increase risks of complications. Rapid recovery from anaesthesia with protective airway reflexes without pain is a challenge for the anaesthiologist. So, FESS is challenge for the surgeons and anaestheologists. Early and pain free recovery with return of protective airway reflex are the main anaesthetic goals in the postoperative period. General anesthesia combined with regional analgesic block can be used to depress intra and postoperative painful stimuli. Regional blocks are better than high doses of narcotics to avoid their side effects as postoperative nausea, vomiting, respiratory depression and decreased alertness.The anterior and internal portions of the nose are innervated by branches of the sphenopalatine ganglion and the anterior ethmoidal nerves. Therefore, most postoperative pain is induced by stimulation of these nerve branches. Dexmedetomidine (DEX) is a potent a 2-adrenoceptor agonist. It was recorded that dexmedetomidine was effective in different regional anaesthesia and neuraxial block . Duration of sensory blockade was prolonged when dexmedetomidine injected perineurally in the peripheries.
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 01/04/2020
Actual trial start date
Anticipated date of last follow up 01/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine group After induction of anaesthesia, the transoral sphenopalatine ganglion (SPG) block and endonasal anterior ethmoidal nerve blocks will be performed for each side. The mixture of local anaesthetic for this group will be 5 ml bupivacaine 0.5% (Aldebeiky pharma Egypt) with 1 ml normal saline for total volume 6 ml solution. single time Transoral SPG block: The 25-gauge needle will be bent 25 mm from the tip at a 45° angle to ensure safe and effective deli¬very 2 ml desired solution for each side. The needle will be inserted into the greater palatine foramen, traversing the greater palatine canal into the pterygo¬palatine fossa. Endonasal anterior ethmoidal nerve block: AEN block will performed by endoscopic endo¬nasal submucosal infiltration of the agger nasi cell and middle turbinate region with 1ml desired solution for each side, which achieves blockade of the anterior lateral nasal branch of the nerve. The mixture of local anaesthetic for this group will be 5 ml bupivacaine 0.5% (Aldebeiky pharma Egypt) with 1 ml normal saline for total volume 6 ml solution. 30 Active-Treatment of Control Group
Experimental Group dexmedotomidine group After induction of anaesthesia, the transoral sphenopalatine ganglion block (SPG) and endonasal anterior ethmoidal nerve blocks will be performed for each side. The mixture of local anaesthetic for this group will be 5 ml bupivacaine 0.5% with dexmedetomidine 1µg/kg in volume of 1 ml (Pfizer, USA) for total volume 6 ml solution. single time Transoral SPG block: The 25-gauge needle will be bent 25 mm from the tip at a 45° angle to ensure safe and effective deli¬very 2 ml desired solution for each side. The needle will be inserted into the greater palatine foramen, traversing the greater palatine canal into the pterygo¬palatine fossa . Endonasal anterior ethmoidal nerve block: AEN block will performed by endoscopic endo¬nasal submucosal infiltration of the agger nasi cell and middle turbinate region with 1ml desired solution for each side, which achieves blockade of the anterior lateral nasal branch of the nerve. The mixture of local anaesthetic for this group will be 5 ml bupivacaine 0.5% with dexmedetomidine 1µg/kg in volume of 1 ml (Pfizer, USA) for total volume 6 ml solution. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will involve in the research if they will schedule for FESS due to failure of medical treatment, aged more than 18 years of both sex, and have ASA physical status I-II Pregnant, lactating mother patients with psychological problems who can’t comply with the protocol patients with systemic disease affecting the nose. pre-existing chronic facial pain of other aetiology, patients who are taking regular analgesia, antidepressant and/or antiepileptic medications, history of drug allergy, those with bleeding diathesis or on anticoagulant therapy . Adult: 18 Year(s)-44 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 24/02/2020 research ethical committe
Ethics Committee Address
Street address City Postal code Country
El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain measured by Visual analogue Scale (VAS) postopertive period
Secondary Outcome the time of the first dose of rescue analgesia postoperative period
Secondary Outcome Intraoperative hemodynamic measurement intraoperative peroid
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals 1, algeish st, tanta, algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tarek abdel hay abdel latif el guindy st. from omar ibn abdel aziz st., tanta qasim 2, tanta, el gharbia governate, egypt tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university 1, algeish st, tanta, algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
tarek abdel hay abdel latif mostafa 1, algeish st, tanta, algharbia governate, egypt tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tarek mostafa dr.tarek311@yahoo.com 0201003591332 1, algeish st, tanta, algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries bsant kasem bsantsafwat16120167@gmail.com 0201095750853 1, algeish st, tanta, algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 0201283929049 El Bahr St.Tanta Qism 2, Tanta, Gharbia Governorate, Egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes non identified patients data will be available with the principle investigator for 6 months after publication of the paper Study Protocol 6 months from publication of the paper dr.tarek311@yahoo.com
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