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.: PACTR202203681520134 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rhomboid intercostal and sub serratus plane block after laparoscopic cholecystectomy
Official scientific title Rhomboid intercostal and sub serratus plane block for postoperative analgesia after laparoscopic cholecystectomy: a randomized control study
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy (LC) is the gold standard in many health centers as it is less invasive compared to open cholecystectomy as it reduces bleeding, lower surgical site infection rates, decreased costs, shorter hospital stay, earlier return to the daily routine, and enhances recovery. Despite all these advantages of laparoscopic surgeries, early postoperative pain is displeasing, even can lead to prolonged hospital stays. Pain transmission after abdominal surgery is provided by the cutaneous branches of the thoracolumbar T6-L1 nerves in the anterolateral region. Multimodal analgesia regimens are used for postoperative analgesia after abdominal surgery, including laparoscopic cholecystectomy. For this purpose, short-acting opioids, NSAIDs, and regional anesthesia techniques are used in combination. Current rational analgesia management guidelines recommend opioids only if needed and encourage the usage of multimodal analgesic methods, which can decrease the use of postoperative opioids. Rhomboid intercostal and subserratus (RISS) block provides analgesia from the third to 12th thoracic dermatomes and has been used in postoperative pain management for thoracic surgeries. Although it is used for postoperative analgesia after upper abdominal surgery, there are no adequate studies on its use in laparoscopic cholecystectomy operations. Theoretical target dermatomes (T3-T12) of the RISS block may include areas that cause pain in laparoscopic cholecystectomy operations, including trocar insertion sites. It has been suggested in several reports that incisional pain can be more predominant than visceral pain during the postoperative 48 hours. Therefore, in this study, we aimed to evaluate the effect of RISS block on postoperative analgesic consumption in laparoscopic cholecystectomy surgeries.
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: Other
Anticipated trial start date 15/04/2022
Actual trial start date
Anticipated date of last follow up 10/03/2023
Actual Last follow-up date 10/04/2023
Anticipated target sample size (number of participants) 90
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention till the end of the surgery All patients in this group will not receive Rhomboid intercostal and subserratus (RISS) block 45 Placebo
Experimental Group Rhomboid intercostal and sub Serratus block Group before skin incision after initiation of general anesthesia All patients in this group will receive 30mL 0.25% bupivacaine to perform the rhomboid intercostal and sub Serratus block 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age between 20 and 65 years. • Both sexes. • American Society of Anesthesiologists (ASA) classes I or II. • Age beyond the previous limits. • ASA class > II. • Bleeding disorders. • Skin infection at the site of injection. • The presence of psychiatric illness. • History of opioid abuse. • Known allergy to the study medications. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 11/11/2021 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board- IRB- 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 Amount of postoperative analgesic requirements total amount of post-operative analgesics will be recorded. over 24h
Secondary Outcome Post-operative pain measured by VAS score VAS score will be assessed immediately after the procedures, 1h, 3h, 6h, 12h, and 24h postoperatively.
Secondary Outcome time of the First analgesic request. The time to first analgesic request will be recorded immediately postoperative.
Secondary Outcome Hemodynamic changes between the two groups at the baseline, and then every 10 min till the end of the procedure
Secondary Outcome Patient satisfaction postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Elgomhouria St., Mansoura City, Egypt Mansoura City 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Gad Elhouty Elgomhouria St., Mansoura City, Egypt Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhouria St., Mansoura City, Egypt Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elhouty mohamedsarah862@gmail.com 01093019320 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mostafa Elawady sasaelawady@gmail.com 01004062862 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Mohamed Elhouty mohamedsarah862@gmail.com 01093019320 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate 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