Transdermal Buprenorphine Patch in the Management of Postoperative Acute Pain Following Mandibular Resection and Reconstruction.

Background: Transdermal buprenorphine is used for the management of postoperative pain. Its effectiveness for the postoperative pain management following mandibular resection and reconstruction has yet to be evaluated.

Purpose: To evaluate the efficacy of transdermal buprenorphine patch (TBP) in managing postoperative pain after mandibular resection and reconstruction with anterior iliac crest graft.

Study design, setting and sample: This triple-blinded, randomized controlled trial included 30 subjects in the age range of 18 to 60 years with benign mandibular pathologies. Subjects visiting the outpatient department of the Dept. of Dentistry, All India Institute of Medical Sciences, Bhubaneswar, India, were included in the study. Subjects with known allergies to any drugs, using sedatives, alcohol, pregnant and lactating mothers, and with respiratory problems were excluded.

Predictor: The predictor variable was postoperative pain management and subjects were randomly assigned to TBP or a placebo patch group.

Main outcome variable: It was the postoperative pain, which was measured by visual analog scale (VAS) for 7 consecutive days. Secondary outcome variables were requirement of rescue analgesics and drug-related adverse effects.

Covariates: Age at surgery, sex, diagnosis, duration of the operation, and amount of fentanyl used during the operation were covariates.

Analyses: Descriptive statistics, Mann-Whitney U test, χ², repeated measures analysis of variance, and post-hoc analysis (Bonferroni test) were used. A P value <.05 was considered a level of statistical significance.

Results: Thirty subjects were randomly allocated to TBP and control group. The mean VAS score during the study period was 0.8 ± 2.37, and 3.49 ± 2.37 in TBP and control group subjects respectively (P < .001). Compared to control group, the mean VAS score in TBP group subjects were significantly less till the end of postoperative day 4 (P < .001). The mean rescue analgesic requirement during the postoperative period was 5.33 ± 15.8 mg and 47.6 ± 37.7 mg in the TBP and control group subjects, respectively (P < .001). Nausea was the most common drug-related adverse effect in both the group subjects (46.7%) (P > .9).

Conclusion and relevance: The highest VAS score in TBP group subjects was 1.53 ± 0.92 on the morning of postoperative day 1, whereas it was 6.47 ± 1.3 at 6 hours after operation in control group subjects. Thus, a TBP was adequate for the management of postoperative pain following mandibular resection and reconstruction.