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.: PACTR202210738525707 Date of Approval: 03/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of adding fentanyl to bupivacaine in ultra-sound guided erector spinae plane block (ESPB) in modified radical mastectomy surgeries.
Official scientific title Effect of adding fentanyl to bupivacaine in ultra-sound guided erector spinae plane block (ESPB) in modified radical mastectomy surgeries.
Brief summary describing the background and objectives of the trial Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as erector spinae plane block were used as an analgesia for breast surgeries. Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help 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.we will study the effect of adding fentanyl as an adjuvant to bupivacaine in erector spinae plane block wich aims at decrease hospital stay amd post operative opioids 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 01/10/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 01/09/2023
Actual Last follow-up date 01/09/2023
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status 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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adding fentanyl to bupivacaine in erector spinae plane block Single injection of: Bupivacaine 0.5% added to 9 ml normal saline +1ml fentanyl(50 mcg) Single injection at the end of surgery ,15-20 mins before injection of muscle relaxant reversal. Skin sterilization will be done first then a high frequency linear probe will be placed in a longitudinal parasagittal plane approximately 3c.m 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 an 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 ultrasound imaging 60
Control Group Injection of bupivacaine only in erector spinae plane block Single injection of bupivacaine 10 ml+10 ml normal saline At the end of surgery 15-20 mins before injection of muscle realaxant reversal Skin sterilization will be done first then a high frequency linear probe will be placed in a longitudinal parasagittal plane approximately 3 cm 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 an 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 ultrasound imaging 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age:30-65years Physical status: ASA I,II patients after taking written and informed consent. BMI<35 Age:<30 and >65 years Refusal of procedure or participation in the study by the patient. Physical status: ASA III or above. History of allergy to the study drug. BMI>35 Bleeding disorders and coagulopathy. Psychiatric illness that may interfere with the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 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 06/07/2022 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 El Abbassia Square,Near Al-Nour mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to measure the total amount of nalubuphine consumed within 24 hours. Immediately postoperative till 24 hours post operative
Secondary Outcome The secondary outcome will be the first time to request rescue analgesia. Immediately post operative 24 hours postoperative.
Secondary Outcome Post-operative pain assessment using the Visual Analogue Scale (VAS). It consists of a 10 cm straight line with the endpoints defining extreme levels of ‘NO pain at all’ (0 cm) and ‘pain as bad as it could be’ (10 cm). Immediately post operative,1,2,6,12,24 hours post operative.
Secondary Outcome Recording the patients hemodynamics as regard blood pressure and heart rate. Immediately post operative,1,2,6,12,24 hours post operative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine.Ainshams university 38 Abbassia Square,Next to Al-Nour Mosque. Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Ali el kassar street El shrouk 11837 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine.Ainshams university 38 Abbassia Square,Near Al-nour mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Karim ahmed ismail ahmed Ali el kassar st,3rd neigbhourhood,villa 99 El shrouk 11837 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Abdel aziz Tulin377@hotmail.com 01119758252 49 abdel hakim rafaey street,Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer in departement of anesthesia.Faculty of medicine.Ainshams university.
Role Name Email Phone Street address
Public Enquiries Karim Ismail Kimoism3il_91@yahoo.com 01099921196 Ali el kassar st,3rd neigbhourhood
City Postal code Country Position/Affiliation
El shrouk 11837 Egypt Assisstant lecturer of anaethesia.Faculty of medicine.Ainshams university.
Role Name Email Phone Street address
Scientific Enquiries Reem El kabarity rhkabarity@yahoo.co.uk 01223471902 13 mohammed taalar salem street,nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Professor of anaethesia at faculty of medicine.Ainshams 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