|Year : 2019 | Volume
| Issue : 1 | Page : 2-8
An in vivo double-blind randomized controlled study comparing the postoperative pain in single sitting root canal treatment under bupivacaine versus lignocaine used as a local anesthetic agent
Sumita A Bhagwat, Anacleta Heredia, Leena V Padhye
Department of Conservative Dentistry and Endodontics, DYPU School of Dentistry, Navi Mumbai, Maharashtra, India
|Date of Web Publication||19-Jun-2019|
Dr. Sumita A Bhagwat
406/27 Siddhachal Phase 5, Pokhran Road 2, Thane-West - 400 610, Maharashtra
Source of Support: None, Conflict of Interest: None
Aim: This in vivo double-blind randomized control trial was carried out to evaluate the efficacy of a long-acting local anesthetic bupivacaine in preventing postoperative pain associated with single sitting endodontic treatment and to compare it with lignocaine when used as a local anesthetic agent.
Methods: A total of fifty patients with symptomatic irreversible pulpitis were selected to be included in the study. The patients were randomly divided into two groups: Group A patients were given lignocaine as local anesthetic and Group B were given bupivacaine. The root canal procedures for the patients were carried out in single sittings under rubber dam using hand ProTaper™ system, 2.5% sodium hypochlorite as irrigant alternating with normal saline and obturation by lateral condensation technique. A questionnaire employing visual analog scale for pain assessment was given to the patient and instructions on how to fill the form were given. The patients were recalled after 2 days, and the pain was analyzed. The result was tabulated and statistically analyzed for incidence and degree of pain.
Results: The mean overall postoperative pain for bupivacaine was lesser than that for lignocaine, and the difference was statistically significant.
Conclusion: Based on our findings and in comparison with those of other studies, we reached the conclusion that it may be recommended that bupivacaine may replace lignocaine as the anesthetic of choice in the single visit endodontic protocol in order to reduce the incidence of postoperative pain often seen after single visit endodontic procedures.
Keywords: Bupivacaine, lignocaine, postoperative pain, single sitting root canal treatment
|How to cite this article:|
Bhagwat SA, Heredia A, Padhye LV. An in vivo double-blind randomized controlled study comparing the postoperative pain in single sitting root canal treatment under bupivacaine versus lignocaine used as a local anesthetic agent. Endodontology 2019;31:2-8
|How to cite this URL:|
Bhagwat SA, Heredia A, Padhye LV. An in vivo double-blind randomized controlled study comparing the postoperative pain in single sitting root canal treatment under bupivacaine versus lignocaine used as a local anesthetic agent. Endodontology [serial online] 2019 [cited 2019 Oct 17];31:2-8. Available from: http://www.endodontologyonweb.org/text.asp?2019/31/1/2/260518
| Introduction|| |
Managing postoperative pain can be one of the more challenging aspects of the clinical practice of endodontics and one by which the skill of the clinician is often judged. Good anesthetic technique can eliminate pain during the procedure, but posttreatment endodontic pain remains a significant predicament to date.
The most common factors influencing the occurrence of pain after root canal treatment (RCT) include irrigant extrusion, hyperocclusion, presence of preoperative pain, presence of periapical pathosis, apical debris extrusion, and apical patency during root canal preparation. The greatest intensity of pain has shown a trend to be experienced about 6 h after the appointment, and it decreased thereafter.,, It is usually controlled by the use of mild oral analgesics or nonsteroidal anti-inflammatory drugs. However, nonsteroidal anti-inflammatory drugs may manifest side effects such as gastrointestinal irritation, systemic bleeding tendency, and allergic reactions. These observations justify efforts to find a method of postoperative pain control that does not provoke side effects.
Bupivacaine, a long-acting anesthetic, demonstrates a duration of anesthesia ranging between 7 and 11 h for inferior alveolar nerve block and a mean of 9 h for infiltration. Hypothetically, this extended duration of anesthesia covers the time of greatest incidence and intensity of postoperative pain following endodontic therapy.
Studies have shown that postoperative pain can be reduced if local anesthesia has been achieved by long-acting local anesthetics. Researchers found that 0.5% bupivacaine with 1:200,000 epinephrine when used for inferior alveolar nerve block for first or second mandibular molars had lesser pain score at 6 and 12 h after RCT compared with patients who received 2% lignocaine with 1:80,000 epinephrine, and the use of analgesics was lower than in the lignocaine group. Another study showed that postoperative pain was experienced by 11 patients out of 102 patients receiving 2% lignocaine with 1:80,000 epinephrine and only one patient after the use of 0.5% bupivacaine for lower third molar surgeries.
During the last 20 years, many researchers have conducted studies to determine the efficacy of long-acting local anesthetics versus the more commonly used anesthetic agents. If successful, patients should report less pain and require fewer analgesics postoperatively. Most of these studies found that the prolonged anesthesia that results from the use of long-acting local anesthetics was followed by a period of analgesia. Researchers have demonstrated that there was less postoperative pain and fewer analgesics were required when 0.5% bupivacaine with 1:200,000 epinephrine was used during periodontal surgeries compared to 2% lidocaine with 1:100,000 epinephrine.
Most of the evidence based on PubMed search is on the effect of using long-acting anesthetic on postoperative pain after tooth extraction or periodontal surgery, and this is why such a study is important where the model used is on postoperative pain after RCT., Further, there is minimal clinical research into the comparison of incidence of postoperative pain following single visit endodontics between patients anesthetized with lignocaine and bupivacaine.
Hence, an in vivo double-blind study was proposed to observe the incidence of postoperative pain perception in patients with chronic irreversible pulpitis when the tooth was preoperatively anesthetized with bupivacaine and lignocaine by local infiltration and to compare the observations of both groups.
The study hypothesis proposed was as follows:
Null hypothesis (H0) – The incidence of postoperative pain in single sitting RCT under bupivacaine and lignocaine used as local anesthetic agent is similar.
Thus, if u1 and u2 are the mean values of incidence of postoperative pain for bupivacaine group and lignocaine group, then,
H0: u1 = u2
Alternate hypothesis (H1) – The incidence of postoperative pain in single sitting RCT under bupivacaine and lignocaine used as local anesthetic agent is not similar.
H1: u1 not similar u2
| Methods|| |
Fifty adult patients (39 women and 11 men) with an age range of 15–67 years participated in this randomized double-blind clinical trial. They were selected from the referred patient pool of the Department of Conservative Dentistry and Endodontics, D. Y. Patil University School of Dentistry. The clinical study protocol was reviewed and approved by the University Research Ethical Committee. The trial individuals were treated in accordance with the Declaration of Helsinki.
The inclusion criteria were:
- Healthy controls (American Society of Anesthesiologist I or II) who required endodontic treatment in upper anterior vital teeth with a clinical diagnosis of irreversible pulpitis
- Teeth without a history of root canal therapy
- Teeth without pus or inflammatory exudate draining through the canal
- Teeth without anatomic variations, for example, receded pulp chamber, calcified canals, or sharply curved canals
- Patients not on analgesics or sedative medications before root canal therapy
- Teeth without sinus tract
- Teeth with sound periodontal apparatus.
The exclusion criteria were:
- Patients allergic to amide local anesthetics
- Pregnancy or lactation
- Other endocrine or infectious disease
- Moderate to advanced periodontal disease
- Nonvital teeth (necrosed)
- Retreatment cases
- Teeth with calcified canals
- Teeth with periapical radiolucency.
Fifty single-rooted teeth maxillary central and lateral incisors and canines requiring root canal therapy in male and female patients (15–67 years) were selected for the study. The sample size was based on the earlier reported data for postoperative pain following single visit RCT. All the cases were subjected to vitality testing using electric pulp tester, heat test, and cold test. A preoperative radiograph was taken to check the canals, periodontal tissues, and presence of periapical radiolucency. A thorough clinical examination was carried out, and a detailed case history was taken.
When it was determined that a patient met the criteria of the study, the individual was informed about the nature of the study and their informed consent was taken. Each patient rated their initial pain on a 10 cm visual analog scale (VAS) with a range of no pain (0 cm) and unbearable pain (10 cm).
The patients were then randomly divided into two groups of 25 each. Allocation to the groups was done by a person other than the person performing the root canal procedure. All teeth were treated in a single appointment by the same operator. Bupivacaine was provided from 20 ml vials and inserted into lignocaine cartridges that were emptied and autoclaved previously. The cartridges were coded by a person who was not involved in data collection. Thus, both the operator and the patient were not aware of the anesthetic being administered in each case.
Before administration of the anesthetic, a test dose of 1:10 dilution of 2% lignocaine or 0.5% bupivacaine was administered intradermally on the forearm to determine if the patient was allergic to the local anesthetic. Once it was determined that the patient was not allergic to the anesthetic, the root canal procedure was initiated. Patients in Group 1 received 1.8 ml of lidocaine 2% with 1:80,000 epinephrine. Patients in Group 2 received 1.8 ml of bupivacaine 0.5% without epinephrine. One operator performed all of the anesthetic procedures. After administration of local anesthesia, the tooth was isolated using a rubber dam. Access opening and working length determination were performed by using Ingle's technique. The root canals were instrumented using the crown down technique with hand ProTapers™ (S1–F5) up to working length. Canals were irrigated using sterile saline and 2.5% sodium hypochlorite after each instrument used. Obturation was carried out with Gutta-percha by lateral condensation technique using AH-plus™ root canal sealer. All variables besides the local anesthetic used were standardized consistently.
Patients were instructed to rate any pain occurring during the endodontic procedure using VAS. Treatment was deemed successful if no pain or mild discomfort (VAS score of 0 or 1) was felt during the access preparation and instrumentation. A questionnaire was given to the patients at the end of the appointment. Patients were educated about how to assess and record the incidence and severity of pain at 6, 12, 24, and 48 h after the appointment. Patients were also instructed to contact the clinician in case of severe pain and were assured regarding an escape clause for taking pain medication if required.
Individuals were recalled after 2 days with the questionnaire that was provided on the day of the treatment. In case the patient had to take medications for severe pain, he/she was disqualified from the study. The ratings from the questionnaire were tabulated.
Anesthetic success and the degree of postoperative pain among the two groups were analyzed using the Mann–Whitney and Wilcoxon signed ranks test. Comparisons were also made to evaluate the relation of postoperative pain to the presence of preoperative pain. Comparisons were considered significant if P was < 0.05.
| Results|| |
[Table 1] and [Table 2] give the data distribution as a frequency chart for the pain level ratings of the patients as per responses to the questionnaires in each of the groups and [Graph 1] and [Graph 2] illustrate the same.
|Table 1: Frequency distribution chart of postoperative pain for Group A (lignocaine)|
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|Table 2: Frequency distribution chart of postoperative pain for Group B (bupivacaine)|
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Statistical analysis of the data
After obtaining the responses from the individuals and tabulation of the same, statistical analysis of the data was performed. [Table 3] and [Table 4] give the descriptive statistics of the data obtained and [Graph 3] and [Graph 4] are graphic representations of the same.
|Table 3: Descriptive statistics of postoperative pain for Group A and Group B|
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|Table 4: Descriptive statistics of preoperative pain and postoperative pain for Group A and Group B|
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The degree of postoperative pain among the two groups was analyzed using the Mann–Whitney and Wilcoxon signed ranks test. Comparisons were also made to evaluate the relation of postoperative pain to the presence of preoperative pain. Comparisons were considered significant if P was < 0.05.
[Table 5] and [Table 6] give the analysis of data obtained for Group A and [Table 7] and [Table 8] for Group B. [Table 9] gives the test statistics showing comparison between lignocaine (Group A) and bupivacaine (Group B) groups.
|Table 5: Wilcoxon signed rank test of postoperative pain for Group A (lignocaine)|
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|Table 6: Wilcoxon signed rank test of pre- and post-operative pain comparison for Group A (lignocaine)|
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|Table 7: Wilcoxon signed rank test of postoperative pain for Group B (bupivacaine)|
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|Table 8: Wilcoxon signed rank test of pre- and post-operative pain for Group B (bupivacaine)|
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|Table 9: Test statistics showing comparison between Group A (lignocaine) and Group B (bupivacaine)|
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| Discussion|| |
Discomfort is the main short-term complication of RCT. Studies have shown that the incidence of postobturation discomfort is similar with single sitting and multiple visit endodontics although analgesic usage is significantly less common in patients undergoing multiple visit endodontics. It is possible that during the single visit, the working time is longer, causing a more severe inflammatory response, manifested as pain during the immediate postoperative period. A systematic review of single visit RCT concluded that patients might take more analgesics compared with when the treatment is provided during multiple visits.
After the completion of the RCT, pain generally arises immediately after the cessation of local anesthesia. In patients anesthetized with lignocaine, this is generally seen around 6 h after the administration of the anesthetic.,,
Bupivacaine is a long-acting, water-soluble, amide-linked local anesthetic which is recommended for those procedures in which a painful postoperative period is expected and also for prolonged procedures where reinjection would otherwise be necessary. Bupivacaine (1-butyl-2, 6 pipecoloxylidide hydrochloride) has a chemical structure similar to that of mepivacaine except for a butyl (4 carbon) substitution for the methyl (1 carbon) group at the aromatic amine of mepivacaine. The agent without a vasoconstrictor has a pH of 6.0–6.5, and with epinephrine, it has a pH of 3.5. The long duration of action of bupivacaine is related to its lipid solubility and protein binding properties. Nespeca in 1976 showed that 8 out of 143 patients who had been administered 0.5% bupivacaine with or without epinephrine experienced duration of anesthesia beyond 10 h whereas only one patient out of 119 with 0.25% bupivacaine with or without epinephrine had the same experience. He found that the effect of anesthesia wore out after 6 h for 2% lidocaine with or without epinephrine for infiltration and blocks.
Studies have shown that postoperative pain can be reduced if local anesthesia has been achieved by long-acting local anesthetics. In a study by Parirokh et al. in 2012, the researchers found that 0.5% bupivacaine with 1:200,000 epinephrine when used for inferior alveolar nerve block for first or second mandibular molars had lesser pain score at 6 and 12 h after RCT compared with patients who received 2% lidocaine with 1:80,000 epinephrine, and the use of analgesics was lower than in the lidocaine group. A study by Marković and Todorović in 2006 showed that postoperative pain was experienced by 11 patients out of 102 patients receiving 2% lidocaine with 1:80,000 epinephrine and only one patient after the use of 0.5% bupivacaine for lower third molar surgeries.
In our study, we found that there was a statistical significance in the difference in postoperative pain incidence at 12 and 24 h in the lignocaine group. The difference between the postoperative pain at 12 and 48 h was also statistically significant in this group.
In the bupivacaine group, we found statistical significance when comparing postoperative pain at 12 and 48 h.
From these findings, we conclude that postoperative pain is significantly reduced at 48 h in comparison to that at 12 h irrespective of the anesthetic used.
On comparison of mean postoperative pain at 6, 12, 24, and 48 h, there was a clear statistical significance when comparing readings between the lignocaine and bupivacaine group. There is a clear indication that the postoperative pain experienced by a patient receiving bupivacaine as a local anesthetic will definitely be less than that experienced by a patient receiving lignocaine as a local anesthetic agent when all other variables of single visit RCT are kept constant.
Our findings are in agreement with those of Moradi and Naghavi who found that the mean postoperative pain in the bupivacaine group was lesser than the lignocaine group after root canal therapy. Al-Kahtani found that the level of postoperative pain was higher in lignocaine group compared to the bupivacaine group. The level of pain in lignocaine group had decreased by 24 h whereas in bupivacaine group, it had decreased by 6 and 12 h after root canal therapy. Neal et al. showed that at 24 h, patients who had received lignocaine for periodontal surgery had more pain compared to those who received bupivacaine. Marković and Todorović found that patients who received lignocaine for third molar removal experienced more pain postoperatively than those who received bupivacaine. The postoperative pain was higher in the lidocaine group in the first 6 h. Nespeca found that those who received lidocaine for root canal therapy experienced moderate to severe postoperative pain in the first 6 h. Most patients who received bupivacaine did not experience any postoperative pain, and 4 out of sixty patients experienced early postoperative pain.,
The H0 was therefore disproved and the alternative hypothesis stands conclusive proven.
| Conclusion|| |
After careful evaluation and statistical analysis, the following conclusions were made.
- Postoperative pain after single sitting endodontics is significantly reduced at 48 h in comparison to that at 12 h irrespective of the anesthetic used
- The mean overall postoperative pain for bupivacaine is lesser than that for lidocaine, and this difference is statistically significant
- While the reduction of postoperative pain is significantly reduced by the anesthetic used, there is a definite relationship between quantum of postoperative pain with the presence or absence of preoperative pain. The presence of preoperative pain may be more likely to result in the occurrence of postoperative pain in single sitting root canal therapy irrespective of the local anesthetic employed.
Based on our findings and in comparison with those of other studies, we reached the conclusion that it may be recommended that bupivacaine may replace lignocaine as the anesthetic of choice in the single visit endodontic protocol to achieve postoperative analgesia.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]