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.: PACTR201611001263105 Date of Approval: 12/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Laparoscopy port-site wound infiltration Trial
Official scientific title Laparoscopy port-site wound infiltration with local anaesthetic for postoperative pain relief: A randomized controlled trial
Brief summary describing the background and objectives of the trial Laparoscopic procedures are becoming more frequent and are one of the most common major operative procedures performed worldwide for investigation of infertility1. It is increasingly replacing open surgery as the preferred treatment option in most patients across disciplines. It has also been established as the golden standard for the surgical treatment of a variety of benign tumours and other pathologic conditions2,3. Today, operative laparoscopy is routinely used by gynecologists to perform a multitude of procedures, including hysterectomies and incontinence procedures, and for the diagnosis and treatment of gynecologic malignancies. Infertility is an emotional experience for a woman and her husband. The woman needs to return home and return to work immediately after laparoscopic procedure devoid of pain. Any form of intervention that leads to improvement in pain relief can positively impact on the quality of life. Prompt and adequate postoperative pain relief is therefore an important component of laparoscopic procedures that can make the period immediately after the operation less uncomfortable and more emotionally gratifying. Postoperative pain after laparoscopy is usually managed with opioids in combination with other forms of analgesic
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Post operative pain
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Other
Anticipated trial start date 12/09/2015
Actual trial start date 01/11/2016
Anticipated date of last follow up 23/01/2017
Actual Last follow-up date 31/05/2017
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 198
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group xylocaine group once STAT For intraincisional infiltration of xylocaine, the fascia, and subcutaneous tissue will be infiltrated using 5 ml for each port. This will be done using a 10 ml syringe and needle inserted through the incision site. All patients will receive analgesics to a standard post-operative protocol with Diclofenac 75 mg intramuscularly at the end of the operation and further 50 mg per oral route twice a da 100
Control Group Placebo once STAT For intraincisional infiltration of placebo, the fascia, and subcutaneous tissue will be infiltrated using 5 ml for each port. This will be done using a 10 ml syringe and needle inserted through the incision site. All patients will receive analgesics to a standard post-operative protocol with Diclofenac 75 mg intramuscularly at the end of the operation and further 50 mg per oral route twice a da 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consent Patients with known allergic reactions to local anaesthetics If the operation had been converted to an open procedure Patients with intra-operative complications. Chronic medical diseases Chronic opioid treatment. 16 Year(s) 65 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 26/03/2015 nauth ethical committee
Ethics Committee Address
Street address City Postal code Country
nnewi onitsha road nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Pain scores using a visual analogue scale. 2. Mortality. 1. Pain scores at different time points (4 to 8 hours) and using a visual analogue scale. 2. Mortality.
Secondary Outcome 1. Analgesic consumption 2. Time to first analgesic request. 3. Serious adverse events related to local anaesthetic wound infiltration such as allergic reactions, fits (convulsions), cardiac arrhythmias, and cardiac arrest. O HOUR 4 HOURS 8 HOURS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NNEWI 435001 Nigeria
LIFE SPECIALIST HOSPITAL LTD IKEMBA DRIVE NNEWI 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
LIFE SPECIALIST HOSPITAL,LTD 49 IKEMBA DRIVE NNEWI NNEWI 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR GEORGE ELEJE NNEWI ONITSHA ROAD NNEWI 435001 Nigeria Charities/Societies/Foundation
Secondary Sponsor LIFE SPECIALIST HOSPITAL,LTD 49 IKEMBA DRIVE NNEWI NNEWI 435001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
DR GEORGE ELEJE NNEWI ONITSHA ROAD NNEWI 435001 Nigeria
PROF JOSEPH IKECHEBELU 49 IKEMBA DRIVE NNEWI NNEWI 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEORGE ELEJE georgel21@yahoo.com +2348068117444 nnewi onitsha road
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria Nnamdi Azikiwe University Teaching Hospital, Nnewi
Role Name Email Phone Street address
Public Enquiries CHIDIMMA OKAFOR donkafson@yahoo.com +2347030528420 49 IKEMBA DRIVE, NNEWI
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria LIFE SPECIALIST HOSPITAL, LTD, NNEWI
Role Name Email Phone Street address
Scientific Enquiries JOSEPH IKECHEBELU jikechebelu@yahoo.com +2348034044189 49 IKEMBA DRIVE, NNEWI
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria Nnamdi Azikiwe University Teaching Hospital, Nnewi
REPORTING
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