Does lidocaine act as a painkiller during colonoscopy?
| ISRCTN | ISRCTN47787339 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47787339 |
| EudraCT/CTIS number | 2016-002210-46 |
| Secondary identifying numbers | NL56640.091.16 |
- Submission date
- 06/02/2019
- Registration date
- 25/02/2019
- Last edited
- 26/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Colonoscopy is a commonly performed procedure to diagnose or follow up an inflammatory bowel disease (IBD) like Crohn’s disease and ulcerative colitis. For some of these patients, this can be a very painful procedure. Propofol anaesthetic in combination with a short-acting opioid painkiller i.e. alfentanil is commonly used for procedural sedation and analgesia (PSA). However, alfentanil can induce some serious adverse effects like low blood pressure, slow heart rate, and slow breathing. Administration of lidocaine during an operation has a proven beneficial effect in abdominal surgery, reducing pain after operation the need for strong opiods. We expect that intravenous lidocaine will reduce the need for alfentanil during colonoscopy.
Who can participate?
Any patient who is undergoing a colonoscopy and is willing to participate in a clinical trial.
What does the study involve?
Participants in the intervention group will receive lidocaine during the normal procedure of colonoscopy. Patients who are included in the placebo group of the study will receive placebo.
What are the possible benefits and risks of participating?
All measurement and handlings to the patients which participate in this study are part of standard care. Patients will have little extra risks due to the known low and non-toxic plasma levels with this commonly used infusing regimen of lidocaine. Monitoring of patients will ensure that any potential side effect or adverse event are noticed and treated as quickly as possible.
The benefit for the patients can be that less alfentanyl needs to be given during colonoscopy, which can lead to less negative side effects like hypotension, respiratory depression and PONV.
Where is the study run from?
Radboud Universitair Medisch Centrum, Geert Grooteplein Zuid 10, Nijmegen, 625 GA, Netherlands
When is the study starting and how long is it expected to run for?
The study will run from November 2016 to November 2018.
Who is funding the study?
Radboud Universitair Medisch Centrum, Netherlands.
Who is the main contact?
Mr. Twan Aalbers, twan.aalbers@radboudumc.nl
Contact information
Public
Radboud Universitair Medisch Centrum
Geert Grooteplein Zuid 10
huispost 717
Nijmegen
6525 GA
Netherlands
| Phone | +31243614406 |
|---|---|
| twan.aalbers@radboudumc.nl |
Study information
| Study design | Single centre double-blinded randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Does intravenous lidocaine reduce the need for alfentanil during colonoscopy under procedural sedation and analgesia? |
| Study acronym | LiSA |
| Study objectives | We hypothesize that intravenous lidocaine reduces the need for alfentanil during colonoscopy |
| Ethics approval(s) | Approved 01/09/2019, Human Research Committee region Arnhem-Nijmegen (p/a Radboudumc, house post 628, P.O. box 9101, 6500 HB Nijmegen, The Netherlands; +31 24 361 3154; commissiemensgebondenonderzoek@radboudumc.nl), ref: 2016-2624 |
| Health condition(s) or problem(s) studied | Healthcare domain: procedural sedation and analgesia (PSA) |
| Intervention | intervention: At the start of PSA, patient will receive 1.5 mg/kg intravenous bolus, followed by a continuous infusion of 2 mg/kg/h lidocaine during the colonoscopy. Patients who are included in the placebo group of the study will receive saline in equivalent volumes and time. At the end of the colonoscopy subjects will be monitored until they reach an Aldrete recovery score of nine or higher and for at least 30 minutes according to the local PSA protocol. Afterward, patients will be discharged. A letter with instructions is sent to the general practitioner. All adverse events reported spontaneously by the subject of observed by the investigator or his staff will be recorded. Serious adverse events have been reported to the accredited local ethics committee. 76 patients are randomized to either intravenous lidocaine treatment or placebo by the research unit of the anesthesiology department. The subjects were randomized into groups that resulted in equal sample sizes. There were two treatment groups (treatment medication (A) versus placebo (B)). Treatment A and B were written on pieces of paper, equal amounts of A and B. The pieces of paper were put into an envelope and blindly selected one at a time. The first paper drawn was assigned to the first patient, the second was assigned to the second subject and so on. Two research coordinators were present during this randomization process. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Lidocaïne 1% |
| Primary outcome measure | Alfentanyl dose (mcg) required to maintain a score < 4 on the Facial Pain Rating Scale (Wong baker face scale) during the procedure. |
| Secondary outcome measures | 1. Total propofol dose (mcg) required to maintain sedation level 4-5 on The Ramsey Sedation Scale during the procedure. 2. Infusion time measured in minutes from delivery to end of sedation. 3. Incidence of oxygen desaturation (defined as < 92%) measured continuously during the procedure. 4. Incidence of hypotension (defined as mean arterial pressure < 60 mmHg) measured every 5 minutes during the procedure. 5. Pain score measured using the numerical rating scale after the procedure. 6. Incidence of postprocedural nausea and vomiting measured by patient interview after the procedure. 7. Incidence of adverse effects of lidocaine (e.g. tinnitus, blurred vision or double vision, metal taste during procedure) measured by patient interview after the procedure. |
| Overall study start date | 09/06/2016 |
| Completion date | 27/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 76 |
| Total final enrolment | 76 |
| Key inclusion criteria | 1. Colonoscopy performed under PSA 2. Age 18-65 years 3. Inflammatory bowel disease: Crohn’s disease or ulcerative colitis 4. Informed consent 5. ASA classification 1 or 2 |
| Key exclusion criteria | 1. Pregnancy 2. Emergency colonoscopy 3. Allergies for study medication 4. Rhythm disorders i.e. first, second or third degree AV block 5. Brugada syndrome 6. Cardiomyopathy 7. BMI >35 8. BMI <18 9. Obstructive sleep apnea syndrome 10. Uncontrolled hypertension |
| Date of first enrolment | 24/11/2016 |
| Date of final enrolment | 13/11/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nijmegen
6525 GA
Netherlands
Sponsor information
Hospital/treatment centre
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
| Phone | +31(0)243614406 |
|---|---|
| twan.aalbers@radboudumc.nl | |
| Website | www.radboudumc.nl |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans are to publish the findings of this study in a prominent magazine in the work field of anesthesiology or gastroenterology |
| IPD sharing plan | The datasets generated during and the current study will be available upon request from Twan Aalbers (twan.aalbers@radboudumc.nl). Type of data: SPS datasheet. Data will become available after publication and is available until January 2034. Data will be shared in the context of scientific research. No informed consent has been given from participants. Only anonymous data is available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 18/11/2019 | 29/11/2019 | No | No | |
| Results article | 30/07/2020 | 22/08/2022 | Yes | No | |
| Protocol file | version 4 | 01/10/2016 | 26/08/2022 | No | No |
Additional files
- ISRCTN47787339 _BasicResults_18Nov19.pdf
- Uploaded 29/11/2019
- 36315 Protocol v4 01Oct2016.pdf
Editorial Notes
26/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
22/08/2022: Publication reference added.
29/11/2019: IPD sharing statement added. The basic results of this trial have been uploaded as an additional file.
18/11/2019: Total final enrolment number added.
