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.: PACTR202210507488378 Date of Approval: 13/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparative Study between Dexmedetomidine and Dexamethasone as an Adjuvant to Bupivacaine in Ultrasound Guided Interscalene Block for Arthroscopic Shoulder Surgery
Official scientific title A Comparative Study between Dexmedetomidine and Dexamethasone as an Adjuvant to Bupivacaine in Ultrasound Guided Interscalene Block for Arthroscopic Shoulder Surgery
Brief summary describing the background and objectives of the trial Arthroscopic shoulder surgery is now performed for many surgical indications such as rotator cuff muscle tear, stiffness, instability and shoulder impingement. An appropriate pain control is an important factor for recovery after shoulder arthroscopy as controlling pain can help in increasing patient satisfaction, early rehabilitation and improving the outcome postoperatively. Interscalene block is usually preferred for shoulder surgery as a perioperative analgesia for decreasing opioid need, minimizing hospital stay and for decreasing postoperative complications caused by pain as frozen shoulder. In this study we will compare between dexmedetomidine and dexamesathone as an adjuvant to bupivacaine to prolong the action of interscalene block and decreasing postoperative analgesics requirements.
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 postoperative pain management
Anticipated trial start date 15/08/2022
Actual trial start date
Anticipated date of last follow up 15/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group interscalene block 15 ml of 0.2% bupivacaine single injection 10-20 minutes before skin incision After induction of general anesthesia while the patient is still in supine position and under complete aseptic conditions, Marking external landmarks including the clavicle, interscalene groove, and lateral border of the clavicular sternocleidomastoid muscle will be done, The ultrasound technique (using linear probe) consisted of an “in-plane” posterior approach at the level of the cricoid cartilage; visualizing the great vessels, sternocleidomastoid, and scalene muscles will be considered; scanning caudally, until the brachial plexus nerve roots/trunks will be identified as hypoechoic structures between the anterior and middle scalene muscles. A 15 ml volume of local anesthesia solution prepared as 6 ml of bupivacaine and 9 ml of normal saline (bupivacaine 0.2%) will be injected after negative aspiration divided over the 3 trunks (superior, middle and inferior trunk). 30 Active-Treatment of Control Group
Experimental Group Dexmedetomidine as an adjuvent to Bupivacaine for interscalene block 15 ml bupivacaine 0.2% containing 0.1 μg/kg of dexmedetomidine single injection 10-20 minutes before skine incision After induction of general anesthesia while the patient is still in supine position and under complete aseptic conditions, Marking external landmarks including the clavicle, interscalene groove, and lateral border of the clavicular sternocleidomastoid muscle will be done, The ultrasound technique (using linear probe) consisted of an “in-plane” posterior approach at the level of the cricoid cartilage; visualizing the great vessels, sternocleidomastoid, and scalene muscles will be considered; scanning caudally, until the brachial plexus nerve roots/trunks will be identified as hypoechoic structures between the anterior and middle scalene muscles. A 15 ml volume of local anesthesia solution prepared as 6 ml of bupivacaine and 9 ml of normal saline (bupivacaine 0.2%) containing 0.1 μg/kg of dexmedetomidine will be injected after negative aspiration divided over the 3 trunks (superior, middle and inferior trunk). 30
Experimental Group dexamesthesone as an adjuvent to Bupivacaine for interscalene block 15 ml bupivacaine 0.2% containing 8 milligrams of dexamesthasone single injection 10-20 minutes before skin incision After induction of general anesthesia while the patient is still in supine position and under complete aseptic conditions, Marking external landmarks including the clavicle, interscalene groove, and lateral border of the clavicular sternocleidomastoid muscle will be done, The ultrasound technique (using linear probe) consisted of an “in-plane” posterior approach at the level of the cricoid cartilage; visualizing the great vessels, sternocleidomastoid, and scalene muscles will be considered; scanning caudally, until the brachial plexus nerve roots/trunks will be identified as hypoechoic structures between the anterior and middle scalene muscles. A 15 ml volume of local anesthesia solution prepared as 6 ml of bupivacaine and 9 ml of normal saline (bupivacaine 0.2%) containing 8 milligrams of dexamesthasone will be injected after negative aspiration divided over the 3 trunks (superior, middle and inferior trunk). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients American Society of Anesthesiologists physical status (ASA) is I to II. 2. Both gender. 3. Aged group from 21 to 50 years old. 4. Patients electively scheduled for arthroscopic shoulder surgery under general anesthesia with normal coagulation profile. 1. Refusal of the procedure or participation in the study. 2. Any history or evidence of coagulopathy. 3. Evidence of infection at injection site. 4. Past history allergy to local anesthetics. 5. Patients with advanced medical diseases such as (renal failure, cardiac, respiratory, liver or neurological diseases). 6. Failed interscalene block and the need of post-operative narcotics. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 50 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 28/07/2022 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome first time needed and total amount of analgesia given intra-operatively and first time needed for analgesics as a rescue analgesia post-operatively. From time of skin incison till 24 hours postoperative
Secondary Outcome total amount of ketorolac used with maximum dose of 90 mg per day and occurrence of side effects of drugs and it’s time. 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fasculty of Medicine Ain Shams University 38 Abbassia Square Next to Al-Nour Mosque Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
peter nashaat el rehab group 105 building 14 apartment 23 cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Peter Nashaat Ramzy el rehab group 105 building 14 apartement 23 cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar Mohamed Taha Abdallah ElSafty cairo cairo Egypt
Sherif George Anis Saeed cairo cairo Egypt
Amin Mohammed AlAnsary Amin cairo cairo Egypt
Engy Samy Attia Samy cairo cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Youwakiem dr.peternashaat@gmail.com +201003733917 el rehab group 105 building 14 apartment 23
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries omar Elsafty drosafty61@yahoo.com +201000665666 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Sherif Saeed sherifganis@hotmail.com +201222421674 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Amin Alansary aminalansary@yahoo.com +201007962192 cairo
City Postal code Country Position/Affiliation
cairo Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Engy Samy engy.sami1@yahoo.com +201276404274 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Peter Youwakiem dr.peternashaat@gmail.com +201003733917 el rehab group 105 building 14 apartment 23
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trial, after de-identification Study Protocol following publication any purpose
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