Treatment of pain following keyhole surgery in West Africa
| ISRCTN | ISRCTN17667918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17667918 |
- Submission date
- 27/06/2018
- Registration date
- 03/07/2018
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Department of Surgery, Obafemi Awolowo University
Ile-Ife
220005
Nigeria
Study information
| Study design | Feasibility randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17667918_PIS_03Jul2018.pdf |
| 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 objectives | 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(s) | Ethics and Research Committee of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria, May 2015, IRB/IEC/0004553 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/10/2014 |
| Completion date | 30/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 69 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease |
| Key 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 |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Ile-Ife
220005
Nigeria
Sponsor information
University/education
P.M.B. 13
Ile-Ife
220282
Nigeria
| Website | https://www.oauife.edu.ng |
|---|---|
"ROR" |
https://ror.org/04snhqa82 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication is anticipated in an international surgical journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/07/2018 | 02/04/2019 | No | Yes | |
| Results article | results | 26/03/2019 | 04/04/2019 | Yes | No |
Additional files
- ISRCTN17667918_PIS_03Jul2018.pdf
- Uploaded 02/04/2019
Editorial Notes
09/08/2019: PubMed link added.
04/04/2019: Publication reference added.
02/04/2019: The participant information sheet has been uploaded.
