Lidocaine and epinephrine mixture relieves pain from impacted molar surgery
| ISRCTN | ISRCTN13866362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13866362 |
| Secondary identifying numbers | 42/2016 |
- Submission date
- 27/09/2024
- Registration date
- 01/10/2024
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Mandibular third molars (the teeth at the back of the lower jaw) typically erupt in humans between 18 and 24 years of age. Accordingly, the lower third molar will commonly become impacted (stuck in the gum) and will have to be removed. However, discomfort and adverse effects may occur following an impacted tooth extraction such as edema (swelling), numbness, and excessive bleeding. Pain is the most prevalent problem following impacted tooth extractions. Pain perception affects individuals differently. The pain experienced from dental extraction and dental anesthesia can produce different responses among patients.
Local anesthetic drugs such as lidocaine and mepivacaine are used to alleviate pain during surgery or dental work. However, certain side effects, including redness, swelling, itching, dizziness, drowsiness, nausea, and, rarely, severe allergic reactions, have been observed with lidocaine . Bupivacaine reduced pain after impacted tooth extraction but did not decrease analgesic drug intake. Furthermore, irrigation of the tooth socket with bupivacaine after removal of the impacted third molar could significantly reduce the discomfort of the patient when compared to normal saline (salt water) irrigation.
The aim of this study is to compare the analgesic effects of lidocaine and bupivacaine compared with normal saline solution irrigation in patients after surgical removal of mandibular third molars.
Who can participate?
Patients aged between 18 and 25 years with impacted third molars
What does the study involve?
Participants are randomly allocated to receive lidocaine or bupivacaine post-operatively. Either molar side was randomly selected for the initial surgery and flushed with anesthetics before suture removal. Patients were then evaluated for pain levels and asked to respond to questionnaires at 2, 4, 6, and 8 hours. Another tooth was surgically extracted after 4 weeks and patients were monitored as they had been for the previous surgery.
What are the possible benefits and risks of participating?
Irrigation of lidocaine plus epinephrine could help reduce pain after wisdom tooth extraction/surgery in the early stages, even though the effect of the injected anesthesia is somewhat reduced. In addition, the irrigation will allow the patients not to bite on gauze, which may be inconvenient to take painkillers such as paracetamol or/and ibuprofen. Moreover, this technique is very helpful for postoperative patients, especially in cases where there may be severe pain after surgery due to a difficult time-consuming operation with a high pain response.
There may be a risk of a dry socket but the percentage is very low, and some patients may be allergic or hypersensitive to the epinephrine.
Where is the study run from?
Chiang Mai University (Thailand)
When is the study starting and how long is it expected to run for?
October 2014 to December 2019
Who is funding the study?
Chiang Mai University (Thailand)
Who is the main contact?
Assistant Professor Dr. Vuttinun Chatupos, vuttinunch@yahoo.co.th
Contact information
Public, Scientific, Principal Investigator
Department of Biochemistry
Faculty of Medicine
Chiang Mai University
Chiangmai
50200
Thailand
 ORCID ID |
0000-0002-5706-8781 |
|---|---|
| Phone | +66 (0)810353463 |
| somdet.s@cmu.ac.th |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | 46142_PIS_V2.pdf |
| Scientific title | Evaluation of the effectiveness of lidocaine with epinephrine irrigation in reducing acute pain from surgical removal of mesioangular-impacted third molars |
| Study objectives | Lidocaine would exert not only systemic anaesthetic but also local anti-pain properties to be used in postoperative patients with mesioangular impacted molars. |
| Ethics approval(s) |
1. Approved 03/12/2014, Chiang Mai University (Faculty of Dentistry, Chiangmai, 50200, Thailand; +66 (0)53944445; anak.ia@cmu.ac.th), ref: 52/2014 2. Approved 24/08/2016, Chiang Mai University (Faculty of Dentistry, Chiangmai, 50200, Thailand; +66 (0)53944445; anak.ia@cmu.ac.th), ref: 52/2014 |
| Health condition(s) or problem(s) studied | Impacted lower mandibular molars |
| Intervention | Participants were randomly divided by block randomization to receive 2% lidocaine or 0.5% bupivacaine post-operatively. Either molar side was randomly selected for the initial surgery and flushed with anesthetics before suture removal. Patients were then evaluated for pain levels using the Visual Analog Scale (VAS) tool and asked to respond to questionnaires at 2, 4, 6, and 8 hours. Another tooth was surgically extracted after 4 weeks and patients were again monitored, as they had been for the previous surgery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lidocaine, epinephrine |
| Primary outcome measure | 1. Duration of surgery and postoperative irrigation volume of NSS or lidocaine plus epinephrine used, recorded after surgery 2. Pain is measured using the visual analogue score (VAS) at baseline, 24, 48 and 72 hours 3. Number of paracetamol consumed, recorded after surgery 4. VAS-aided assessment of pain measured in participants receiving bupivacaine or lidocaine at 2, 4, 6, and 8 hours post-operation |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2014 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | 1. Aged between 18 and 25 years 2. Systemically deemed to be healthy 3. Orthodontically indicated for impacted lower third molar on both sides as depicted in panoramic radiographs 4. Non-allergic to amoxicillin and paracetamol 5. Had not previously experienced inflammation or infection of the teeth and gums around the lower molars before treatment |
| Key exclusion criteria | 1. History of neurological disorders 2. Allergies to lidocaine and bupivacaine 3. Received steroid medication |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Oral and Maxillofacial Surgery
Faculty of Dentistry
Chiang Mai
50200
Thailand
Sponsor information
University/education
Department of Biochemistry
Faculty of Medicine
Chiangmai
50200
Thailand
| Phone | +66 (0)53944429 |
|---|---|
| cmdj.dent@cmu.ac.th | |
| Website | http://www.dent.cmu.ac.th/mdj/frontend/web/?r=site/viewdata&id=7 |
"ROR" |
https://ror.org/05m2fqn25 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NRCT
- Location
- Thailand
Government organisation / Universities (academic only)
- Alternative name(s)
- Chiang Mai University, THAILAND, มหาวิทยาลัยเชียงใ, มหาวิทยาลัยเชียงใหม่, 清迈大学, CMU
- Location
- Thailand
Results and Publications
| Intention to publish date | 15/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in peer-reviewed journals |
| IPD sharing plan | The dataset generated during and/or the current study will be available upon request from Professor Dr Somdet Srichairatanakool, PhD, somdet.s@cmu.ac.th |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 01/10/2024 | No | Yes | |
| Protocol file | version 2 | 01/10/2024 | No | No | |
| Results article | 17/12/2024 | 17/01/2025 | Yes | No |
Additional files
Editorial Notes
17/01/2025: Publication reference added.
02/10/2024: Internal review.
30/09/2024: Study's existence confirmed by Chiang Mai University.
