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.: PACTR202307885435649 Date of Approval: 27/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of adding dexmedetomidine as adjuvant to bupivacaine in ultra-sound guided erector spinae plane block for post modified radical mastectomy pain management
Official scientific title Effect of adding dexmedetomidine as adjuvant to bupivacaine in ultra-sound guided erector spinae plane block for post modified radical mastectomy pain management
Brief summary describing the background and objectives of the trial Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime . Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries. Erector spinae plane block is a newer interfascial plane block first described by Forero et al in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations. Later studies have shown that ESPB can provide effective analgesia in breast surgeries. Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications. Adjuvants to local anasthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect. this study aims to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.
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: Drugs
Anticipated trial start date 15/07/2023
Actual trial start date 01/08/2023
Anticipated date of last follow up 05/06/2024
Actual Last follow-up date 05/06/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Experimental Group Erector Spinae Plane Block 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine (1 μg/kg). At the end of surgery ,just before patient recovery the patient will be placed in the lateral position. Skin sterilization will be done first then a high frequency linear probe will be placed in a longitudinal parasagittal plane approximately 3 cm away from midline. After identifying the erector spinae muscle superficial to the tip of T5 transverse process,An echogenic needle of 22G will be inserted with in-plane approach in a cranio-caudal manner till it contacts with the tip of transverse process .After slight retraction of the needle the local anaesthetics will be injected after negative aspiration to avoid intravascular injection and the spread of the drug will be observed in tissue plane under ultrasonic visualization 30
Control Group Erector Spinae Plane Block 20 ml Bupivacaine 0.25% added to 1 ml normal saline. At the end of surgery , just before patient recovery the patient will be placed in the lateral position. Skin sterilization will be done first then a high frequency linear probe will be placed in a longitudinal parasagittal plane approximately 3 cm away from midline. After identifying the erector spinae muscle superficial to the tip of T5 transverse process,An echogenic needle of 22G will be inserted with in-plane approach in a cranio-caudal manner till it contacts with the tip of transverse process .After slight retraction of the needle the local anaesthetics will be injected after negative aspiration to avoid intravascular injection and the spread of the drug will be observed in tissue plane under ultrasonic visualization 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age :30-65years. 2- Physical status: ASA I,II. 3- BMI<35. 4- Localized breast cancer. 1- age:<30 and >65 years. 2- Refusal of procedure or participation in the study by the patient. 3- Physical status: ASA III or above. 4- History of allergy to the study drug. 5- BMI>35. 6- Bleeding disorders and coagulopathy. 7- Psychiatric illness that may interfere with the study. 8- Metastatic breast cancer. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 Year(s) Female
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 09/07/2023 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the first time to request rescue analgesia, pain score and patient hemodynamics. from the end of the surgery to the first time to request rescue analgesia
Secondary Outcome The secondary outcome is to measure the total amount of nalubuphine consumed within 24 hours. from the first time to request rescue analgesia till 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The Principle Investigator 26 Abbassia St.,Abbassia Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abanoub Mouris Feltaoos Fabib 26 Abbassia St.,Abbassia Cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Abanoub feltaoos Abanoubmoureshabib@gmail.com +201283575659 26 Abbassia St.,Abbassia
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Assistant Lecturer in Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Hatem Said hatemsabdelhamid@gmail.com +201022068269 79 Mohy El-Din ,Nasser city
City Postal code Country Position/Affiliation
Cairo Egypt Professor at Anesthesia Department . Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa ahmadabdulmageed@gmail.com +201000560552 5th Settelement
City Postal code Country Position/Affiliation
Caieo Egypt Lecturer at Anesthesia Department . Faculty of Medicine Ain Shams University
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