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.: PACTR202207699902119 Date of Approval: 18/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block Versus Subcostal Transversus Abdominis Block in Open Upper Abdominal Surgeries
Official scientific title Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block Versus Subcostal Transversus Abdominis Block in Open Upper Abdominal Surgeries
Brief summary describing the background and objectives of the trial This study is designed to compare between analgesic effect of rhomboid intercostal and subserratus plane block (RISS) and subcostal Trasnsversus abdominis block in open upper abdominal surgeries Upper abdominal surgeries are defined as any surgical procedure performed through an incision above or extending above the umbilicus . Upper abdominal surgeries cause severe abdominal pain, which if not treated adequately can cause certain problems to the patients as shallow breathing, postoperative atelectasis, and retention of airway secretions which increase the incidence of postoperative morbidity and lead to delayed recovery
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 Prevention
Anticipated trial start date 01/08/2022
Actual trial start date 01/09/2022
Anticipated date of last follow up 01/08/2023
Actual Last follow-up date 01/09/2023
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants) 74
Recruitment status Not yet 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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subcostal Transversus Abdominis Block group 30mL ( 15 mL bupivacaine 0.25%+15 mL saline) in each side 24 hours After induction of general anesthesia and intubation of patients. Patients will be placed in supine position. After sterilization of the skin, a high frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall along the subcostal margin near the midline. The rectus abdominis muscle is identified first. Then the ultrasound probe is gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle can be identified lying posterior to the rectus muscle. After identification of the neurofascial plane (TAP) between the rectus abdominis and the transversus abdominis muscle, an 18-gauge spinal needle will be introduced anteriorly in the plane of ultrasound beam. The needle is directed to approach the transversus abdominis plane and on entering the fascial plane, 15 mL of bupivacaine 0.25% plus 15 mL normal saline are injected after negative aspiration. The transversus abdominis plane can be seen as a dark oval pocket due to hydrodissection. The same steps are done on the opposite side. We will follow up the following data: - Duration of surgery. - Heart rate and blood pressure (basal preoperative, after 15 minutes, after 30 minutes, and every half an hour till end of the surgery). - Time of the first post-operative morphine dose. - Cumulative morphine consumption at 6, 12, 24 hours. - Pain scores measured by VAS at rest and on movement at 2, 4, 6, 12, 24 hours. - The incidence of side effects (nausea, vomiting, and pruritus). - Incidence of intraoperative hypertension and tachycardia. - Patient satisfaction. - Length of hospital stay 37 Active-Treatment of Control Group
Experimental Group Rhomboid intercostal and subserratus plane block group 30 mL (15 mL bupivacaine 0.25%+15 mL saline) in each side 24 hours After induction of general anesthesia and intubation of patients. Patients will be placed in the lateral decubitus position with arms abducted and internally rotated to move inferior angle of the scapula laterally. After skin sterilization, a high frequency linear ultrasound probe (6-13 MHz) will be placed in the sagittal plane medial to the medial border of the scapula with the orientation marker directed cranially. The transducer will be then rotated so the cranial end will be directed slight medially and caudal end laterally to acquire a paramedian sagittal oblique image 1–2 cm medial to the scapular edge. The following structure will be recognized from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between rhomboid major and intercostal muscles will be identified. An 18-gauge spinal needle will be inserted craniocaudally using an in-plane technique through the trapezius and rhomboid major. After confirming the correct placement of the needle tip by hydrodissection, 10 ml of the injectate (5 mL of bupivacaine 0.25% plus 5 mL normal saline) will be injected into the plane between the rhomboid major and intercostal muscles. After that, to identify the subserratus plane, the transducer will be slided caudally and laterally, distal to inferior angle of the scapula. The following tissue layers will be recognized from superficial to deep: latissimus dorsi, serratus anterior, intercostal muscles between ribs, pleura, and lung. The needle will be advanced at the same skin entry site for rhomboid intercostal injection but will directed caudally and laterally beyond the inferior angle of the scapula. If the needle tip did not reach beyond the inferior edge of the scapula (eg, obese and tall habitus), a new skin entry point medial to the lower angle of the scapula and posterior axillary line will be used then 20 ml of the injectate (10 mL of bupivacaine 0.25% plus 10 mL normal saline) will be injected in the tissue plane between the serratus anterior and external intercostal muscle, hydrodissecting the tissue plane between the serratus anterior muscle and the attachments of the serratus to the rib, and after that the same steps of the block will be done in the opposite side 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients Both genders Aged between 40 and 65 years American society of Anesthesiologists physical status (ASA) I and II Undergoing open upper abdominal surgeries Patients with neuromuscular diseases bleeding or coagulation disorders pregnant women body mass index (BMI) more than 35 kg/m2 Infection at the site of injection Allergy to any of medications used in this study Middle Aged: 45 Year(s)-64 Year(s) 40 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 15/06/2022 Medical Research Ethics Committee. Institutional Review Board. Mansoura Faculty of Medicine. Mansoura University
Ethics Committee Address
Street address City Postal code Country
Elbahr street Mansoura 35555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cumulative morphine consumption at 24 hours postoperatively 24 hours postoperatively
Secondary Outcome - Time to the first post-operative morphine dose. - Cumulative morphine consumption at 6, 12 hours postoperatively. - Pain scores measured by VAS score at rest and on movement at 2, 4, 6, 12, 24 hours postoperatively. - The incidence of postoperative side effects (nausea, vomiting, and pruritus) - Patient satisfaction. - Length of hospital stay. - Incidence of intraoperative hypertension and tachycardia. 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gastroenterology Center. Mansoura University. Gihan street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine. Mansoura University Elgomhoria street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine. Mansoura University Elgomhoria street Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amer Abdallah Attia Elgomhouria street Mansoura 35555 Egypt
Mohammed Adel Hegazy Elgomhouria street Mansoura 35555 Egypt
Mohamed Ahmed Tolba Elgomhouria street Mansoura 35555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ashraf Hafez Hussein mahafez2008@gmail.com +201066906332 Ahmed Maher street
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant lecturer of Anesthesia and Surgical Intensive Care. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Public Enquiries Amer Abdallah Attia dramer2008@mans.edu.eg +201223982731 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of Anesthesia and Surgical Intensive Care. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Adel Hegazy dr_mhegazy7000@mans.edu.eg +201002025982 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor of Anesthesia and Surgical Intensive Care. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Ahmed Tolba M_atolba1234@mans.edu.eg +201012066699 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of Anesthesia and Surgical Intensive Care. Faculty of Medicine. Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participants data and share it through the Pubmed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participants 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