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.: PACTR201506001145361 Date of Approval: 16/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of post-cesarean pain After Intraperitoneal Lidocaine Instillation versus intravenous lidocaine
Official scientific title Evaluation of post-cesarean pain After Intraperitoneal Lidocaine Instillation versus intravenous lidocaine
Brief summary describing the background and objectives of the trial Objective of the study is to compare between the effect of intraperitoneal lidocaine installation and the intravenous lidocaine injection on postoperative pain and analgesic requirements in patients undergoing cesarean section.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,analgesia and prevention of pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/01/2015
Actual trial start date 12/01/2015
Anticipated date of last follow up 15/04/2015
Actual Last follow-up date 15/04/2015
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 110
Recruitment status Completed
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intraperitoneal instillation group patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure single shot intraperitoneal instillation group) (n=55 women): patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure 55
Control Group intravenous infusion group Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion one hour after operation intravenous group) (n= 55 women): Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Singleton pregnancy, 2-more than or equal completed 37 gestational weeks, 3-indicated to undergo elective cesarean delivery for various indications e.g., primigravida with breech presentation, macrosomia, intrauterine growth restriction and contracted pelvis, 4-willing to participate in the study. 1-extreme of age (below 18 ¿ above 40 year), 2-uncooperative patients, 3-previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, 4-BMI >35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, 5-bronchial asthma, 6-bleeding diathesis, 7-pregnancy induced-hypertension, 8-liver or kidney diseases, 9-diabetes mellitus, 9-patients with psychological disturbance, 10-any form of chronic pain before or during pregnancy 18 Year(s) 40 Year(s) Female
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 12/05/2015 research and ethics committee-benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
saha street from farid nada street, new benha street benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score 4, 6, 12, 24 hours post-operative
Secondary Outcome analgesic requirements 4, 6, 12, 24 hours post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university hospital saha street from farid nada street, new benha city, benha benha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
benha university hospital saha street from farid nada street, new benha city, benha benha 13518 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor benha university hospital saha street from farid nada street, new benha city, benha benha 13518 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelaal Ahmed Mahmoud 39 mousa ebn nousir street, 7th district, nasr city, cairo cairo 11471 Egypt
Ahmed mostafa saha street from farid nada street, new benha city, benha benha 13518 Egypt
Mohamed Abd Elhadi Mohamed Farag saha street from farid nada street, new benha city, benha benha 13518 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelaal Ahmed Mahmoud carnitin7@yahoo.com 00201113308866 39 mousa ebn nousir street, 7th district, nasr city
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, beni suef university
Role Name Email Phone Street address
Public Enquiries Mohamed Abd Elhadi Mohamed Farag Mohamed.farah01@fmed.bu.edu.eg 0020 1227858660 saha street from farid nada street, new benha city
City Postal code Country Position/Affiliation
benha 13518 Egypt assistant professor of obstetric and gynecology, faculty of medicine, benha university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mostafa bashaahmed@yahoo.com 00201005204130 saha street from farid nada street, new benha city
City Postal code Country Position/Affiliation
benha 13518 Egypt assistant professor of anesthesiology, faculty of medicine, benha university
REPORTING
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