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.: PACTR202206548559545 Date of Approval: 15/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided maxillary nerve block for perioperative pain management for patients undergoing endoscopic sinus surgery: Randomized control trial
Official scientific title Ultrasound guided maxillary nerve block for perioperative pain management for patients undergoing endoscopic sinus surgery: Randomized control trial
Brief summary describing the background and objectives of the trial Functional endoscopic sinus surgery (FESS) is known to be a treatment of choice in cases nasal polyps, chronic inflammatory para-nasal sinus diseases and chronic rhino-sinusitis. Patients undergoing FESS liable for an unanticipated overnight hospital admission, and for early hospital readmission due to nasal bleeding, pain, or intolerance of nasal packing or dressing. Challengeable aspects facing the anesthesiologist during FESS are airway management considerations for facilitating surgical access and safe emergence from anesthesia, without associated bucking or straining to prevent laryngospasm, and also minimize post-extubation hypertensive responses and resulting profuse microvascular bleeding. Adequate postoperative analgesia for different levels of pain potentially decreases inflammatory cytokines released as a result of pain, leading to diminished subsequent analgesic requirements. Furthermore, improvement of immediate postoperative pain to minimize discomfort and obtain patient satisfaction. Multimodal analgesia can help to keep opioid use to a minimum and provide effective pain control through the use of the regional nerve blocks. Regional anesthesia for maxillofacial surgery has been reported to reduce intraoperative stress responses and perioperative opioid consumption, providing a better and more safe anesthesia technique. The maxillary nerve (MN) block was first described in the early 20th century for dental purposes. It has recently been prescribed for various indications, as cleft palate surgery, oral and orthognathic surgery and maxillary bone fractures. The ultrasound guided suprazygomatic approach at the level of the suprazygomatic angle has been suggested as the safest, easiest, and most reliable approach to the pterygopalatine fossa ( PPF) for the MN block. It prevents penetration of the base of the skull and the orbit, and the bony landmarks are more superficial and more easily palpated which simplifies block performance and improve
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/06/2022
Actual trial start date
Anticipated date of last follow up 19/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maxillary nerve block local anesthetic dose will be bilateral 1.5 mL bupivacaine 0.5% and 1ml dexamethasone additive Once before endoscopic sinus surgery Bilateral maxillary nerve block guided by ultrasound the needle will be directed to the pterygopalatine fossa 30
Control Group Conventional balanced anaesthesia and analgesia According to hemodynamics From start of anesthesia and 48 h postoperative Conventional balanced anaesthesia and postoperative analgesia 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients at the American Society of Anesthesiologists (ASA) physical status I or II, Candidates for endoscopic sinus surgery (refractory or resistant chronic rhinosinusitis or polyps). Patients with uncontrolled hypertension, diabetes, cardiovascular or cerebrovascular diseases Patients with chronic renal diseases Allergy to any of the study drugs Body-mass index higher than 40 kg/m² Unwilling to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 02/06/2022 Research Ethics Committee REC Faculty of Medicine Ain Shams University FWA 000017585
Ethics Committee Address
Street address City Postal code Country
Abbassyia, El-Khalyfa El-Mamoun street Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Numerical Rating Scale (NRS) pain score immediately after anesthesia in PACU, 6, 12, 24, 36 and 48 h after the operation
Primary Outcome Mean arterial blood pressure immediately after anesthesia in PACU, 6, 12, 24, 36 and 48 h after the operation
Primary Outcome Heart rate immediately after anesthesia in PACU, 6, 12, 24, 36 and 48 h after the operation
Secondary Outcome The analgesia boluses (rescue analgesia) within the postoperative 48 hours
Secondary Outcome Adverse effects (Headache, nausea and vomiting, bleeding) within the postoperative 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Inpatient in department of surgery Ain shams university Abbassyia, El-Khalyfa El-Mamoun street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minatallah ali mohamed elshafie Yassen abd elghaffar Shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of surgery Ain shams university Abbassyia, El-Khalyfa El-Mamoun street Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Minatallah Ali Elshafie Yassen Abd elghaffar Shebin elkom 32511 Egypt
Ahmed mahmoud maarouf Abbassyia, El-Khalyfa El-Mamoun street Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Minatallah elshafie menna80mas@gmail.com 00201112248935 Yassen abd elghaffar
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia and Surgical Intensive Care National Liver Institute Menoufia University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Ahmed maarouf maarouf_ent@yahoo.com 00201005264390 Abbassyia, El-Khalyfa ElMamoun street
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant Professor of Otorhinolaryngology Ain Shams University Cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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