Abstract
BackgroundTransdermal buprenorphine is used for the management of postoperative pain. Its effectiveness for the postoperative pain management following mandibular resection and reconstruction has not been evaluated. PurposeTo 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 sampleThis 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 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. PredictorThe predictor variable was postoperative pain management and subjects were randomly assigned to TBP or a placebo patch group. Main outcome variableIt was the postoperative pain, which was measured by visual analog scale (VAS) for seven consecutive days. Secondary outcome variables were requirement of rescue analgesics and drug-related adverse effects. CovariatesAge at surgery, sex, diagnosis, duration of the operation and amount of fentanyl used during the operation were covariates. AnalysesDescriptive statistics, Mann-Whitney U, Chi-square, Repeated Measures ANOVA and post-hoc analysis (Bonferroni test) were used. A P-value <0.05 was considered as a level of statistical significance. ResultsThirty 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<0.001). Compared to control group, the mean VAS score in TBP group subjects was significantly less till the end of post-operative day-4 (P<0.001). The mean rescue analgesic requirement during post-operative period was 5.33±15.8mg and 47.6±37.7mg in the TBP and control group subjects (P<0.001). Nausea was most common drug-related adverse effect in both the group subjects (46.7%) (P>0.9). Conclusion and RelevanceThe highest VAS score in TBP group subjects was 1.53±0.92 on post-operative day-1 morning, 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 post-operative pain following mandibular resection and reconstruction.
Published Version
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