Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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,

Trial website

Contact information



Primary contact

Dr Adewale Adisa


Contact details

Department of Surgery
Obafemi Awolowo University

Additional identifiers

EudraCT number 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


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


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

See additional files


Pain following laparoscopic cholecystectomy


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



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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged 18 years or older
2. Undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Obafemi Awolowo University Teaching Hospitals Complex
Ilesa Road

Sponsor information


Obafemi Awolowo University

Sponsor details

P.M.B. 13

Sponsor type




Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2019 results in: (added 04/04/2019)

Publication citations

Additional files

Editorial Notes

09/08/2019: PubMed link added. 04/04/2019: Publication reference added. 02/04/2019: The participant information sheet has been uploaded.