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.: PACTR202001650544315 Date of Approval: 28/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intragstric instillation of lidocaine in gastric sleeve surgery, a feasibility dose finding study.
Official scientific title Intragstric instillation of lidocaine in gastric sleeve surgery, a feasibility dose finding study.
Brief summary describing the background and objectives of the trial Obesity is a major health problem affecting every organ system and is associated with many health consequences(Berman, Porter and Graber, 2003; Soleimanpour et al., 2017; Esen Tekeli et al., 2019). Weight reduction surgery is the best alternative treatment for extreme obese patients who cannot lose weight by diet, exercise, and weight loss medications(Pokhriyal et al., 2016). After sleeve gastrectomy, optimal postoperative analgesia ensures adequate ventilation and pulmonary mechanics and reduces the risk of postoperative chest infections. The use of opioids in the perioperative period in obese patients is associated with an increased risk of complications(Lam and Mui, 2016). Obese patients are especially more sensitive to the respiratory depressant effect of opioids, thus any analgesic alternative without further compromising airway tone would be a desirable choice. Use of opioid-sparing techniques during anesthesia has attracted substantial research(The Association of Anaesthetists of Great Britain and Ireland, 2007; Dority, Hassan and Chau, 2011; Pokhriyal et al., 2016). Lidocaine, a local anesthetic that has been applied in multimodal strategies to minimize postoperative pain was evaluated in obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo(Berman, Porter and Graber, 2003; Bowman and Jones, 2006). In this study, a new route for lidocaine; intragstric lidocaine, will be assessed regarding postoperative analgesic requirement (primary goal), Patient satisfaction, surgical complications (dehiscence, nausea, vomiting).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/01/2020
Actual trial start date
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group C 24 hours after sleeve gastrectomy • Group C: methylene blue will be diluted in 50 cc normal saline and injected as regular through the bougie lumen. 25 Active-Treatment of Control Group
Experimental Group Group L 24 hours after sleeve gastrectomy methylene blue will be diluted in lidocaine 1% (50 cc) and injected as regular through the bougie. The surgeon will be instructed to keep the antral compression for 2 minutes. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Morbid obese patients scheduled for gastric sleeve gastrectomy Patients with severe cardiac and pulmonary disability, redo-surgeries, patient refusal and known allergy to lidocaine will be considered as exclusion criteria Adult: 19 Year-44 Year 18 Year(s) 45 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 18/01/2020 Institutional research board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative analgesic requirement morphine consumption in milligrams 24 hours after surgery
Secondary Outcome Time to start intestinal motility 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university Elgomhoreya Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Kandeel Elgomhoreya Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed elmorshedi Geihan street MAnsoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes results tables, Figures and study protocol will be available Clinical Study Report,Informed Consent Form,Study Protocol 12 month after trial end Researchers requesting data under control of independent board ( IRB,ethical committee)
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