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.: PACTR202206871825386 Date of Approval: 29/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Laparoscopic Assisted versus Ultrasound Guided Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
Official scientific title Laparoscopic Assisted versus Ultrasound Guided Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Bariatric surgery is currently considered the most effective treatment option for morbid obesity; it results in greater improvement in weight loss outcomes and obesity-related comorbidities when compared with non-surgical interventions, regardless of the type of surgical procedure used. Enhanced recovery pathways are the standard of care in elective bariatric surgery and include a bundle of standardized protocols applied to all patients to improve postoperative outcomes and reduce postoperative length of stay and cost. Transversus abdominis plane (TAP) block has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAP block was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (lap) TAP blocks have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration. It seems to offer an effective local pain control to the patients. TAP block is delivered in the fascial plane between the internal oblique and transversus abdominis muscles targeting the somatic nerves T6–L1 which run in this plane. Several techniques are currently used to deliver TAP blocks, including blinded double POP technique, ultrasound-guided and laparoscopic-assisted approaches. The latter was first described in 2011 by Chetwood et al. while performing laparoscopic nephrectomies. The advantages of this technique include ease of performance, less dependency on specialized skill set or equipment and avoidance of intraperitoneal local anesthetic infiltration. There is a paucity in studies comparing laparoscopic TAP and US TAP techniques. We hypothesize that laparoscopic TAP block is as effective as ultrasound TAP block in patients undergoing laparoscopic bariatric surgery. The aim of this study is to find if the laparoscopic assisted TAP block is non-inferior to ultrasound guided
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Morbid Obesity,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laparoscope assisted Transversus Abdominis Plane block LTAP Group NA Once LTAP blocks will be performed by the operating surgeon at the end of surgery. The camera will be positioned for visualization of the lateral region of the abdominal wall and an 18G laparoscopic needle will be introduced at the center of the midaxillary line between the lower costal margin and the iliac crest via a working port under direct vision until the surgeon felt a “pop”, after which the surgeon injected 2 mL of normal saline to verify the correct position. Doyle’s internal bulge sign, the bulge created when the transversus abdominis muscle with peritoneum is pushed internally will also be noted, after which 20 mL 0.25% bupivacaine will be injected in each side. 60
Control Group Ultrasound Guided Transversus Abdominis Plane Block ULAP Group NA Once UTAP blocks will be performed at the end of surgery by an anesthesiologist with considerable experience in ultrasound-guided nerve blocks. A high frequency linear transducer was placed at the midaxillary line between the lower costal margin and the iliac crest. Upon visualization of the transversus abdominis, the anesthesiologist will place a 22G Tuohy needle in the space between the internal oblique and transversus abdominis muscles using an in-plane ultrasound-guided technique and injected 2 mL of saline to verify the needle placement: subsequently, 20 mL of 0.25% bupivacaine will be injected in each side. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status II-III Body mass index (BMI) ≥ 35 kg/m2 undergoing laparoscopic bariatric surgeries. Prior laparotomy BMI ≥ 60 kg/m2 History of cardiac arrhythmia Diagnosis of “chronic pain syndrome”, allergy to bupivacaine and known alcohol or substance abuse within the last 6 months Daily opioid intake. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 19/06/2022 Research Ethics Committee REC Faculty of Medicine Ain Shams University FWA 0006379
Ethics Committee Address
Street address City Postal code Country
56 ramsis street Abbasya Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total postoperative opioids consumption During the first 24 hours postoperatively
Primary Outcome post-operative pain scores both at rest and movement. 2, 6, 12, 24 hours postoperatively
Secondary Outcome Time of first analgesic requested by patient During the first 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery department Ain Shams University Ramsis Street Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Karim sabry Abd el samee Atia 13 saada st Maadi Cairo 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Surgery Ain shams university Ramsis Street Cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Karim sabry Abd el samee Atia 13 saada st, Maadi Cairo 11728 Egypt
Mohamed foad Elgayar 13 elnadi street Tanta Gharbia Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Atia Karim_sabry@med.asu.edu.eg 00201033335498 13 saada st,Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Assistant Professor of Surgery Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elgayar dr.mohamedfouad78@gmail.com 00201111645345 13 elnadi street, Tanta, Gharbia
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Anesthesiology Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr ElSheikh University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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