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.: PACTR201808607220790 Date of Approval: 23/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CONTINUOUS LOCAL ANAESTHESIA WOUND INFILTRATION VERSUS EPIDURAL ANALGESIA FOR ELECTIVE LAPAROTOMY IN AGA KHAN UNIVERSITY HOSPITAL NAIROBI
Official scientific title CONTINUOUS LOCAL ANAESTHESIA WOUND INFILTRATION VERSUS EPIDURAL ANALGESIA FOR ELECTIVE LAPAROTOMY IN AGA KHAN UNIVERSITY HOSPITAL NAIROBI
Brief summary describing the background and objectives of the trial Epidural analgesia is effective modality of post operative pain control however it is costly and fraught with complications. Continuous local anaesthesia wound infiltration(CLAWI) use has shown reduced pain scores and opioid consumption in other surgical disciplines. The study aims to evaluate effectiveness of CLAWI as compared to epidural analgesia in patients undergoing elective abdominal surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2018
Actual trial start date
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Continuous local anaesthesia wound infiltration bupivacaine 0.125 % and fentanyl 2mcg/ml as continuous infusion titrated to effect at between 4-10ml/hr 72 hours Infiltrate local anaesthesie mixed with opioid through multi hole catheter placed subfascially during abdominal closure 34
Control Group epidural analgesia bupivacaine 0.125% and fentanyl at 2mcg/ml titrated to effect at dose range 4-10ml/hr 72 hours Thoracic epidural analgesia at T9 - T 10 epidural space 34 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patient between 18- 65 years undergoing elective laparatomy Patients undergoing emergency surgery Patients known to have thoraco-lumbar pathology Patients known to have coagulopathy Known bupivacaine or fentanyl hypersensitivity. 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
No 01/10/2018 AKU ethics review committee
Ethics Committee Address
Street address City Postal code Country
3rd parklands Avenue Nairobi 30270 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cumulative opioid use after 72 hours 72 hours
Secondary Outcome dynamic and static visual analogue scores at 24 and 48 hours ,time to return of bowel function, time to first ambulation and local catheter infection rates 24 ,48 hours and 72 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan university hospital 3 rd parklands avenue Nairobi 302700010 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Kenya 3rd Parklands avenue Nairobi 30270 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University 3rd Parklands Avenue Nairobi 30270 Kenya University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Gathege daniel.gathege@aku.edu +254720148045 3rd Parklands avenue
City Postal code Country Position/Affiliation
NAirobi 30270 Kenya Resident
Role Name Email Phone Street address
Public Enquiries Abdallah Abdulkarim abdallah.abdulkarim@aku.edu +254721839112 3rd parklands avenue
City Postal code Country Position/Affiliation
nairobi 30270 Kenya Vice chair department of surgery
Role Name Email Phone Street address
Scientific Enquiries Stanley Mugambi stanley.mugambi@aku.edu +254725103850 3rd parkland avenue
City Postal code Country Position/Affiliation
nairobi 30270 Kenya Faculty department of surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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