Plain English Summary
Background and study aims
Following keyhole surgery patients often experience significant pain and this can delay their return to their normal activities. Some surgeons inject local anaesthetic at the end of the operation into the parts of the abdomen where cuts were made, in order to reduce pain over the first few postoperative hours. However there is no good evidence to support this practice in Nigeria and a large trial is needed to test whether these local anaesthetic injections do reduce pain. The aim of this initial, small study is to find out whether it is possible to run a large-scale randomised study to address this research question in Nigeria.
Who can participate?
Adult patients (18 years or older) undergoing planned keyhole (laparoscopic) surgery for removal of the gallbladder.
What does the study involve?
All participants will receive an injection at the keyhole cut sites. Participants will be randomly allocated to receive either one of two local anaesthetics in the injections, or sterile salt water (saline) only. At four points in the 24 hours following surgery, participants’ pain and nausea will be assessed by a doctor asking simple questions.
What are the possible benefits and risks of participating?
Patients who receive a local anaesthetic reaction may experience better pain control. There is a very low risk of an allergic reaction to the injections administered.
Where is the study being run?
Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria
When is the study starting and how long is it expected to run for?
July 2015 to June 2017
Who is the main contact?
Dr Adewale O. Adisa, wadisc@yahoo.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
Feasibility study for a randomised controlled trial of bupivacaine, lignocaine with adrenaline, or placebo wound infiltration to reduce postoperative pain after laparoscopic cholecystectomy in West Africa
Acronym
Study hypothesis
This trial was designed to determine the benefits of local anaesthetic (bupivacaine or lignocaine with adrenaline) port site infiltration to reduce pain. We aimed to deliver this external feasibility study to determine whether a full phase randomised trial could be delivered.
Ethics approval
Ethics and Research Committee of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria, May 2015, IRB/IEC/0004553
Study design
Feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Pain following laparoscopic cholecystectomy
Intervention
At the end of the procedure, skin, subcutaneous tissue, fascia, and parietal peritoneum will be infiltrated with one of the following solutions:
1. 3 ml of 2% lignocaine with adrenaline in each 10-mm port site and 2 ml in each 5-mm port site (total 200 mg of lignocaine with 1:1000 adrenaline)
2. 3 ml of 0.5% bupivacaine hydrochloride (Marcaine® 0.5%) in each 10-mm port sites and 2 ml in each 5-mm port site (total 50 mg of plain bupivacaine)
3. 3 ml of 0.9% saline in each 10-mm port site and 2 ml in each 5-mm port site.
Intervention type
Drug
Phase
Phase II
Drug names
Bupivacaine, lignocaine with adrenaline
Primary outcome measure
1. Number of patients recruited over a 24 month period
2. Compliance with randomised treatment allocation assessed by the proportion of patients who receive their randomised treatment allocation
3. Outcome assessment completion assessed by the proportion of pain assessments (measured using both the numerical rating scale and verbal rating scale at 2, 6, 12, and 24 hours postoperatively) and nausea assessments (measured using the numerical rating scale measured at 2, 6, 12, and 24 hours postoperatively) that are completed
Secondary outcome measures
Completion of nausea assessment (numerical rating scale) at 2, 6, 12, and 24 hours postoperatively,
Overall trial start date
15/10/2014
Overall trial end date
30/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
1. American Society of Anesthesiology (ASA) physical status class 3+
2. Pregnant women
3. Acute cholecystitis
4. History of allergy to bupivacaine, lignocaine or related local anaesthetic drugs
4. Known peptic ulcer disease
5. Known opiate addiction
6. Known contraindications to use of NSAIDs such as bronchial asthma
7. If an abdominal drain is inserted or the operation was converted to an open procedure, the patient will not receive the allocated intervention and pain scores will not be collected
Recruitment start date
01/07/2015
Recruitment end date
30/06/2017
Locations
Countries of recruitment
Nigeria
Trial participating centre
Obafemi Awolowo University Teaching Hospitals Complex
Ilesa Road
Ile-Ife
220005
Nigeria
Sponsor information
Organisation
Obafemi Awolowo University
Sponsor details
P.M.B. 13
Ile-Ife
220282
Nigeria
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication is anticipated in an international surgical journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as this is a feasibility study designed to inform future trial development, rather than to produce clinical data for the evaluation of specific interventions. However, should a legitimate need arise for the dataset, it will be available upon request.
Intention to publish date
01/09/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31388637 (added 04/04/2019)
Publication citations
Additional files
- ISRCTN17667918_PIS_03Jul2018.pdf Uploaded 02/04/2019