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.: PACTR202306811590520 Date of Approval: 21/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title comparison of the postoperative analgesia of different volumes of bupivacaine for Ultrasound-guided Rhomboid Intercostal Block in patient undergoing Modified Radical Mastectomy: a Randomized Controlled Trial
Official scientific title Efficacy of Two Volumes of Bupivacaine 0.375% on Postoperative Analgesia in Ultrasound-guided Rhomboid Intercostal Block in Modified Radical Mastectomy: a Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Breast cancer is the commonest cancer in females. Modified radical mastectomy is the main procedure for the treatment of breast cancer. Acute pain control prevents surgical response and decreases the need for opioids and analgesics to preserve immune function. Opioids especially morphine may be responsible for higher rates of infection and local recurrence, even metastasis through suppression of both cellular and humoral immunity. As well as previous studies have reported that acute postoperative pain is highly associated with the development of chronic pain. The regional anesthetic technique proved better control of Acute pain and hence less chronic pain. There are many techniques for regional anesthesia in breast surgery. For example, thoracic epidural blockade, thoracic paravertebral blockade, and intercostal nerve blockade are associated with difficulty and higher rates of complications The rhomboid intercostal block is a novel regional analgesia technique that controls pain after surgery involving the chest wall. it is an easy technique and has nearly no complications. This study aimed to compare the postoperative analgesia of two different volumes of bupivacaine for an ultrasound-guided rhomboid intercostal plane block in patients undergoing modified radical mastectomy. This study was a randomized controlled double-blinded study that included 82 patients and was scheduled for modified radical mastectomy under general anesthesia (GA), patients were randomly assigned into 2 equal groups; rhomboid intercostal plane block with 25 ml of 0.375% isobaric bupivacaine in 41 patients (Group V 25) and rhomboid intercostal plane block with 40 ml of 0.375% isobaric bupivacaine in 41 patients (Group V 40).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants)
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rhomboid intercostal block V 25 25 ml of 0.375% bupivacaine after induction The rhomboid intercostal block (RIB) is applied in the area defined as the triangle of auscultation located on the medial edge of the scapula. This area is bounded superiorly by the lower border of the trapezius, inferiorly by the latissimus dorsi, and laterally by the medial border of the scapula. The floor of the triangle is formed by the lower part of the rhomboid major, the lateral portion of the erector spinae muscle, and the serratus anterior muscle, all overlying the 6th and 7th ribs and their internal and external intercostal muscles. (Elsharkawy et al. 2016). The RIB is mainly performed by injection to the upper intercostal muscle plane and below the rhomboid muscles. The patient is positioned in lateral decubitus with the involved breast lying superiorly. The ipsilateral arm was adducted across the chest to move the scapula laterally and opens up this space. A linear ultrasound transducer (6–12 MHz) is placed medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified (Altıparmak et al. 2020(. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T6-7 level. Under the complete aseptic condition, an 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T6-7. After negative aspiration of blood or air, the erector spinae plane was hydro-located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 25mL ( group V 25) of 0.375% bupivacaine according to group allocation will be applied into the interfascial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. All block procedures will be performed by the same anesthesiologist. 57
Control Group Rhomboid intercostal block V 40 40mL of 0.375% bupivacaine after induction The rhomboid intercostal block (RIB) is applied in the area defined as the triangle of auscultation located on the medial edge of the scapula. This area is bounded superiorly by the lower border of the trapezius, inferiorly by the latissimus dorsi, and laterally by the medial border of the scapula. The floor of the triangle is formed by the lower part of the rhomboid major, the lateral portion of the erector spinae muscle, and the serratus anterior muscle, all overlying the 6th and 7th ribs and their internal and external intercostal muscles. (Elsharkawy et al. 2016). The RIB is mainly performed by injection to the upper intercostal muscle plane and below the rhomboid muscles. The patient is positioned in lateral decubitus with the involved breast lying superiorly. The ipsilateral arm was adducted across the chest to move the scapula laterally and opens up this space. A linear ultrasound transducer (6–12 MHz) is placed medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified (Altıparmak et al. 2020(. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T6-7 level. Under the complete aseptic condition, an 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T6-7. After negative aspiration of blood or air, the erector spinae plane was hydro-located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 40mL (group V 40 ) of 0.375% bupivacaine according to group allocation will be applied into the interfascial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. All block procedures will be performed by the same anesthesiologist. Th 57 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Female patients aged between 25-65 years. • ASA physical status I or II. • Scheduled for elective unilateral modified radical mastectomy. • Patient refusal. • Infection at the site of injection. • Hypersensitivity to the local anesthetic. • Bleeding disorders. • Patients with cardiac, hepatic, and renal failure. • BMI ≥40 kg/m2 Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 22/04/2021 Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
institutional research board office- building A - ground floor- faculty of medicine- Mansoura university Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The total analgesic requirements during the first 24 hours Postoperative. after 24 hours
Secondary Outcome • The duration of analgesia (time of first analgesic request). • Postoperative visual analog score (VAS). • Hemodynamics (Intraoperative and Postoperative). • Postoperative complications. after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals el goumhoria st El Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Osama Nasr 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospitals el goumhoria st. Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
mohamed osama fathi nasr 2 elgomhouria street mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed osama nasr m.o.f.nasr@mans.edu.eg +201016007487 2 elgohouria street
City Postal code Country Position/Affiliation
mansoura Egypt assistant lecturer of anesthesia faculty of medicine mansoura university
Role Name Email Phone Street address
Public Enquiries tarek shams m.o.f.nasr@gmail.com +201016007487 2 elgomhouria street
City Postal code Country Position/Affiliation
mansoura Egypt professor of anesthesia mansoura university
Role Name Email Phone Street address
Scientific Enquiries elsayed emam m.o.f.nasr@gmail.com +201016007487 2elgomhouria street
City Postal code Country Position/Affiliation
mansoura Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries ahmed farid m.o.f.nasr@gmail.com +201016007487 2 elgomhouria street
City Postal code Country Position/Affiliation
mansoura Egypt assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant datathat underlie the results,after deidentification (text,tables, figures, andappendices) will be reported.We will individual participate data and shareit through thePubMed indexed journal. IPD that will be generated from this study will be shared upon request from theresearchers andpermission from theUniversity research andpublication director Informed Consent Form Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed-indexed journal
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