Condition category
Surgery
Date applied
27/06/2018
Date assigned
03/07/2018
Last edited
03/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Adewale Adisa

ORCID ID

Contact details

Department of Surgery
Obafemi Awolowo University
Ile-Ife
220005
Nigeria

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

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

https://www.oauife.edu.ng

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

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes