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.: PACTR201611001792336 Date of Approval: 24/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of administration of lidocaine for patients suffering from peritonitis.
Official scientific title Impact of perioperative intravenous lidocaine on postoperative complications rate after laparotomy for complicated intra-abdominal infection in two tertiary university hospitals in Burkina Faso
Brief summary describing the background and objectives of the trial Complicated intra-abdominal infection mortality is high, because of septic shock. Abdominal surgery is associated with respiratory function alteraion, and postoperative ileus in all cases. An extended duration of postoperative ileus has some negative effects on postoperative rehabilitation: -prevents oral feeding associated with metabolic disorders with malnutrition; - increased postoperative infections;- nasogastric tube potentially associated with postoperative pneumonia. Intravenous (IV) lidocaine has analgesic, antiinflamatory, and antimicrobial effects. Positive effects on the duration of postoperative ileus and pain have been demonstrated. These positive effects have been observed for plasmatic concentrations inferior to toxic threshold. Studies showed that lidocaine significantly accelerated return of bowel function after intestinal surgery. First passage of flatus and the first bowel occurred earlier in lidocaine-treated patients compared to placebo recipients. Anesthetic and analgesic techniques that reduce pain and postoperative nausea and vomiting, while reducing postoperative ileus, may reduce postoperative morbidity. Decreasing postoperative ileus, the rate of postoperative pneumonia and anastomotic leak may be decreased. Decreasing systemic inflammation may decrease organ failure (hemodynamic failure, acute kidney injury, acute lung injury). Improving analgesia may accelerate the postoperative rehabilitation, the cough strength and ventilation function, and decrease the duration of hospitalization and improve delay for return to work. The main objective is to assess the effect of perioperative IV lidocaine on the rate of postoperative complications after laparotomy for CAI. Secondary objectives: Assess the impact of IV lidocaine on postoperative analgesia, the duration of postoperative ileus, and postoperative rehabilitation,
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied complicated abdominal infection,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2016
Actual trial start date
Anticipated date of last follow up 03/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 98
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 Computer generated Simple randomisation using a radomisation table created by a computer software program. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous lidocaine 1 mg/kg bolus followed by 1mg/kg/hour 24 hours postoperatively 24 hours Infusion of lidocaine 49
Control Group placebo 50 ml of normal saline followed by infusion of 100 ml of normal saline over 24 hours 24 hours Infusion of normal saline 49 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients Diagnosis of complicated abdominal infection (peritonitis) Informed consent Any organ dysfunction according to SOFA score Allergy to local anesthesic Past history of hepatitis or cirrhosis Abnormal liver tets 18 Year(s) 80 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 comité d'éthique pour la recherche pour la santé
Ethics Committee Address
Street address City Postal code Country
Ouagadougou Burkina Faso
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 05/03/2014 comité d'éthique pour la recherche pour la santé
Ethics Committee Address
Street address City Postal code Country
Avenue du Capitaine Thomas Sankara Ouagadougou 03 BP 702250 31 16 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-type postoperative complications Each day Hôpital discharge
Secondary Outcome Duration of postoperative ileus each 8 hours
Secondary Outcome Hospital length of stay hospital discharge
Secondary Outcome delay for return to work 3 months post-discharge
Secondary Outcome pain scores each 8 hours
Secondary Outcome nausea and vomiting each 8 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CHU Yalgado Ouedraogo Avenue du Capitaine Thomas Sankara Ouagadougou 03 BP 7022 Burkina Faso
Hopital Sourou Sanou avenue du General William Ponty Bobo Dioulasso 01 BP 676 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
CHU Yalgado Ouedraogo Ouagadougou 03 BP 7022 Burkina Faso
CHU Yalgado Ouédraogo Ouagadougou 03 BP 702250 Burkina Faso
CHU Yalgado Ouédraogo Avenue du Capitaine Thomas Sankara Ouagadougou 03 BP 702250 Burkina Faso
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CHU Yalgado Ouedraogo Avenue du Capitaine Thomas Sankara Ouagadougou 03 BP 7022 Burkina Faso Hospital
COLLABORATORS
Name Street address City Postal code Country
Bertille Ki CHU Charles de Gaulle, 979 Boulevard des Tensoba Ouagadougou 01 BP 1198 Burkina Faso
Flavien Kabore CHU Yalgado Ouedraogo, Avenue du Capitaine Thomas Sankara Ouagadougou 03 BP 7022 Burkina Faso
Ibrahim Alain Traore CHU Sourou Sanou, Avenue du gouverneur William Ponty Ouagadougou 01 BP 676 Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bertille Ki bertilleki@yahoo.fr +226 66 79 44 64 979 Boulevard des Tensoba
City Postal code Country Position/Affiliation
ouagadougou 01 BP 1198 Burkina Faso Medical Doctor
Role Name Email Phone Street address
Public Enquiries flavien kabore kflavien@hotmail.com +226 25 31 16 55 Avenue du Capitaine Thomas Sankara
City Postal code Country Position/Affiliation
ouagadougou 03 BP 702250 Burkina Faso Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries pascal augustin pascalaugustin@hotmail.com +33 6 79 68 93 64 Hopital Bichat, 46, rue Henri Huchard
City Postal code Country Position/Affiliation
Paris 75018 France medical doctor
REPORTING
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