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Analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction

Double-blind, randomized controlled trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001138370
Enrollment
50
Registered
2017-08-03
Start date
2014-04-01
Completion date
2016-03-31
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objectives The objective of this randomized controlled clinical trial (RCT) was to compare the effect of bupivacaine and articaine at habitual doses on pain intensity and the need for analgesics after lower third molar extraction. Materials and Methods The final study sample comprised 50 Caucasian volunteers (26 males and 24 females; age range, 18-30 yrs) undergoing scheduled surgical extraction of impacted lower third molar. A computer-generated random sequence was used to allocate participants to the articaine (4%) or bupivacaine (0.5%) group. Measurements were conducted of postoperative pain intensity, using a visual analogue scale (VAS), rescue medication requirement and its timing, and the quality of intraoperative anesthesia. Results VAS-measured pain intensity was significantly higher (p<0.05) in the articaine group than in the bupivacaine group at all time-points except for 8 h post-surgery (p = 0.052). Rescue medication was required by 13 (52%) patients in the articaine group and 8 (32%) patients in the bupivacaine group, although the difference did not reach statistical significance (p=0.252). The groups did not significantly differ (p=0.391) in the quality of the intraoperative anesthesia. Conclusions Bupivacaine is a valid alternative to articaine in third molar surgery and may offer residual anesthesia as a means of reducing postoperative pain. However, further well-designed RCTs are required in larger study populations to verify the effectiveness of bupivacaine to achieve residual analgesia after oral surgery. Clinical relevance. These findings suggest that bupivacaine may be useful as coadjuvant to control acute postoperative pain.

Interventions

Surgical extraction of lower third molars under local anesthesia with bupivacaine were performed. 0.5% bupivacaine with 1:200,000 epinephrine were administered subcutaneously before the surgical extraction. Between 2 and 4 carpules of bupivacaine were administered (2 ml per carpule). The number of carpules depended on the quaility of the intraoperative anesthesia achieved (If patient felt discomfort/pain and additional carpule were administered and recorded in the history)

Sponsors

Master of Oral Surgery and Implant Dentistry, University of Granada, Spain
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

All participants must be undergoning impacted third molar extraction. Caucasian participants, absence of general medical disorders, no allergy to the study medication or related drugs, no receipt of medication with analgesic or anti-inflammatory properties less than 24 h before the surgery, absence of preoperative inflammation and pain at the surgical site, and absence of clinical or radiographic evidence of active oral disease

Exclusion criteria

Age under 18 yrs, renal failure, pregnancy or breast-feeding, allergy to the study medication or related drugs, immunocompromised status, psychological disorder, epilepsy, receipt of medication with analgesic or anti-inflammatory properties less than 24 h before the surgery, preoperative inflammation and pain at the surgical site, and clinical or radiographic evidence of active oral disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026