Does local anaesthesia really give pain relief after dental extraction?
- Conditions
- Periodontal disease, unspecified, (2) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,
- Registration Number
- CTRI/2022/01/039443
- Lead Sponsor
- Manipal College of Dental Sciences Mangalore
- Brief Summary
**Introduction**
Post-operative pain is usually experienced by most of the patients after exodontia and to relief this pain NSAIDS and combination of analgesics are elements of effective pain management. The risk and adverse effects of analgesics are greatly outweighed by the efficacy of the medications. These analgesics are usually used along with other pain management techniques to provide the patient painless surgical procedure.
An alternative to using analgesics, patients can also be given pre-emptive long acting anesthetics. Since the duration of action of the long acting anesthetics persists longer, the interval of pain free periods is increased. Thus the need for regular intake of short acting analgesics is eliminated.
This study is being done to compare two different pain management strategies followed in the clinics.
**AIM AND OBJECTIVES**
**AIM**
Comparative evaluation of effects of long acting anesthetics vs short acting analgesics for relief of post-operative extraction pain for regular intra alveolar extraction of regular molar that is indicated for extraction
**OBJECTIVES**
· To assess the effect of long acting anesthetics for relief of post-operative extraction pain
· To assess the effect of short acting analgesics for relief of post-operative extraction pain
· To compare the effects of Effect of Short Acting local anaesthetic with Analgesics VS Long Acting anaesthetic (0.5% bupivacaine) For Relief of Post-Operative Extraction Pain
**MATERIALS AND METHODS**
This controlled trial is an open study in which patients visiting Manipal College of Dental Sciences, Mangalore will be included. The extractions done by undergraduate students (Interns and final years) will be considered for this controlled trial. An estimated sample size of 50 patients will be considered. Out of this estimated sample size half (i.e. 25 patients) will be administered pre-emptive long acting local anesthesia and the other half (i.e. 25 patients) will be prescribed short acting analgesics.
The patient will be administered with 0.5% Bupivacaine as the long acting local anesthetic or Tablet Ibuprofen 400 milligram (1-1-1) \*2 days i.e. 6 Tablets will be prescribed or mafaenamic acid (Ponstan 500mg). Both the local anesthetic and analgesic are commonly available in the clinics/hospitals.
VAS will be used to analyze the post-operative pain perceived by the patient at 2,4,6,8 and 10 hours. The patients will be called for review after 2 days of extraction.
Errors incurred due to patient ignorance like not taking analgesics on time (at regular intervals) or not taking at all is also included in the study.
Based on the key article the clinic pharmacology drug dev 2017, Christensen seteven et. Al. study titled “Analgesic efficacy of a new immediate release / extended release formulation of ibuprofen†The expected standard deviation is 13.2 with an alpha error of 5%, and a power of 80 %, and keeping an effective difference to show clinically significant difference of 5.5 we need a sample of 46 numbers.
So according to the above mentioned statistics we will include approximately 25 patients in each category making the total sample size 50 (n=50)
**RANDOMIZATION AND ALLOCATION**: randomization will be done using coin flip method, in which heads will be bupivacaine group and tails for ibuprofen group.
Allocation will be done by keeping the details of every patient in separate envelopes
**INCLUSION CRITERIA**Patients visiting Manipal College of Dental Sciences, Mangalore (both male and female of more than 15-year-old.) will be included.
**EXCLUSION CRITERIA** Any diabetic or hypertensive patient or patients with any systemic diseases like asthma will not be included in the study.
**STUDY SETTING**25 patients in each category making the total sample size 50 (n=50) Patients visiting Manipal College of Dental Sciences, Mangalore (both male and female of more than 15-year-old.) will be included.
**STUDY DESIGN** The randomization will be done using coin flip method, in which heads will be bupivacaine group and tails for ibuprofen group. Patient allocation will be concealed by keeping the details in a separate envelope for each patient. Patient given long acting LA will be given the Patient Information sheet having the details of the Principal investigator.
(In case of severe pain contact Ritu Gupta 8170066875 for escape analgesia)
**EXPECTED RESULTS**
It is expected that patients who were administered the long acting anesthetics will have longer pain free periods as compared to those receiving short acting LA and analgesics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients visiting Manipal College of Dental Sciences, Mangalore (both male and female of more than 15-year-old) will be included.
Any diabetic or hypertensive patient or patients with any systemic diseases like asthma or any other systemic condition will not be included in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected that patients who were administered the long acting anesthetics will have longer pain free periods as compared to those receiving short acting LA and analgesics February 2022
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Manipal College of Dental Sciences, Mangalore
🇮🇳Kannada, KARNATAKA, India
Manipal College of Dental Sciences, Mangalore🇮🇳Kannada, KARNATAKA, IndiaRitu GuptaPrincipal investigator8170066875ritugupta0102@gmail.com