Dataset Information

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study.

ABSTRACT:

Background

Cleft lip and palate are common major congenital anomalies. Cleft palate (CP) repair causes pain and needs large doses of intravenous opioids. The risk of postoperative airway obstruction or respiratory depression is high, requiring continuous and vigilant monitoring. The primary outcome was to evaluate the efficacy of using different local anesthetics during bilateral maxillary nerve block (MNB) with general anesthesia on quality of recovery after primary CP repair. We hypothesized that levobupivacaine would be better than bupivacaine. Also, to investigate the potency of bilateral MNB in improving quality of postoperative analgesia.

Methods

Sixty children undergoing primary CP repair surgery were enrolled in the study. Combined general anesthesia and regional bilateral MNB were used for all patients. Group L (n = 30): children received 0.15 ml/kg of 0.2% levobupivacaine, while in Group B (n = 30): children received 0.15 ml/kg of 0.2% bupivacaine.

Results

Face, Legs, Activity, Cry, and Consolability pain score readings were 0 score in 7 cases of the Group L and 10 cases of Group B, 1 score in 14 cases of the Group L and 12 cases of Group B, and 2 score in 9 cases of the Group L and 8 cases of Group B. We found no statistically significant difference between the two study groups as regarding pain score or serious complications.

Conclusions

Levobupivacaine is as effective and safe as bupivacaine to be used for MNB block with a lower incidence of complications. Bilateral suprazygomatic MNB is an effective, easy, and safe method for pain relief in children undergoing primary cleft palate repair surgeries.

SUBMITTER: Mostafa MF

PROVIDER: S-EPMC5903109 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Publications

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study.

Mostafa Mohamed F MF Herdan Ragaa R Elshazly Mohamed M

Korean journal of anesthesiology 20180402 2

<h4>Background</h4>Cleft lip and palate are common major congenital anomalies. Cleft palate (CP) repair causes pain and needs large doses of intravenous opioids. The risk of postoperative airway obstruction or respiratory depression is high, requiring continuous and vigilant monitoring. The primary outcome was to evaluate the efficacy of using different local anesthetics during bilateral maxillary nerve block (MNB) with general anesthesia on quality of recovery after primary CP repair. We hypoth ...[more]

PMID: 29619786

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Project description:Cleft lip with or without cleft palate (CLP) is considered the most frequent congenital malformations of the head and neck, with cleft individuals exhibiting more chances of presenting abnormalities such as developmental defects of enamel (DDE). Matrix metallopeptidase 2 (MMP2) is a membrane-bound protein with collagen-degrading ability and has important roles in tooth formation and mineralization. The aim of this study was to evaluate the frequency, location, severity and extent of DDE found in the maxillary incisors for groups of individuals born with CLP, as well as understanding their relationship with the cleft side. Besides, this study addresses the hypothesis that DDE can be influenced by variation in the MMP2 genes (rs9923304). Individual samples, clinical history, intraoral photographs and panoramic radiographs were obtained from 233 patients under treatment at the Cleft Lip and Palate Service of the University Hospital Lauro Wanderley at the Federal University of Paraíba. Digital images were examined by the same evaluator using the Classification of Defects According to the Modified DDE Index, and then loaded into the Image Tool software, where two measurements were made: total area of the buccal surface (SA) and the area of the DDE (DA), obtaining the percentage of the surface area affected (%SAD) (ICC = 0.99). Genomic DNA was extracted from saliva samples from 124 participants. Genotyping was carried out using TaqMan chemistry for one marker in MMP2 (rs9923304). Statistical analyses were performed by The Jamovi Project software. The Shapiro-Wilk test was applied, followed by the Student's t-test and the Mann-Whitney test. Chi-square and Fisher's exact tests, and odds ratio (OR) with 95% confidence interval (CI) calculations were used to determine Hardy-Weinberg equilibrium and statistically significant differences with an alpha of 0.05. No significant differences in the prevalence and extent of enamel defects were found between male and female individuals born with CLP (p = 0.058256). The frequency of individuals presenting teeth with DDE, in relation to the cleft and non-cleft side, was statistically different (p <0.001; OR = 7.15, CI: 4.674> 7.151> 10.942). However, the averages of %SAD were similar (p = 0.18). The highest means of the %SAD were found in individuals with bilateral cleft lip with or without cleft palate (BCLP) when compared to individuals with unilateral cleft lip with or without cleft palate (UCLP), for the teeth inside (IA) and outside the cleft area (OA) (p <0.001). Regardless of the cleft side, individuals with BCLP were 7.85 times more likely to have more than one third of the tooth surface affected, showing more frequently defects in the three thirds (OA: p <0.001) (IA: p = 0.03), as well as a higher frequency of more than one type of defect (OA: p = 0.000358) (IA: p = 0.008016), whereas in UCLP, defects were isolated and restricted to only one third, more frequently, the incisal third (OA: p = 0.009) (IA: p = 0.001), with greater frequency of milder defects, such as demarcated (p = 0.02) and diffuse (p = 0.008) opacities. A higher frequency of the T allele, less common, was observed in the group of CLP individuals who had all the affected teeth or at least two teeth with %SAD greater than 20% (p = 0.019843). Our results suggest that MMP2 may have a role in the cases that presented DDE and genotyping rs9923304 could serve as the basis for a genomic approach to define risks for individuals born with CLP. Frequency and severity of DDE is strongly related to the CLP phenotype, since the highest values were found for BCLP. However, the extent of the DDE is independent of its relationship with the side of the cleft.

Project description:IntroductionThe association between the treatment of transverse maxillary deﬁciency and the recovery of hearing and voice functions has gained attention in recent years.ObjectiveThis prospective controlled trial aimed to evaluate the effects of rapid maxillary expansion on hearing and voice function in children with non-cleft lip palate and bilateral cleft lip palate with transverse maxillary deficiency METHODS: 53 patients (26 non-cleft and 27 bilateral cleft lip palate; mean age, 11.1±1.8 years) requiring rapid maxillary expansion for correction of narrow maxillary arches were recruited for this trial. Eight sub-groups were established based on the degree of hearing loss. Pure-tone audiometric and tympanometric records were taken for each subject at four different time periods. The first records were taken before rapid maxillary expansion (T0), the second after expansion (T1) (mean, 0.8 months), the third after three months (T2) (mean, 3 months) and the fourth at the end of retention period (T3) (mean, 6 months). ANOVA and Tukey HSD post-hoc tests were used for data analysis. Additionally, voice analysis was done using an updated PRAAT software program in a computerized speech lab at T0 and T2. A paired-samplet-test was used for comparisons of mean values of T0 and T2 voice parameters within both groups.ResultsRapid maxillary expansion treatment produced a significant increase in the hearing levels and middle ear volumes of all non-cleft and bilateral cleft lip palate patients with normal hearing levels and with mild conductive hearing loss, during the T0-T1, T1-T2, T0-T2, and T0-T3 observation periods (p<0.05). The significant increase was observed in right middle ear volumes during the T0-T1, T0-T2 and T0-T3 periods in non-cleft patients with moderate hearing loss. For voice analysis, significant differences were observed only between the T0 and T2 mean fundamental frequency (F0) and jitter percentage (p<0.05) in the non-cleft group. In the cleft group, no significant differences were observed for any voice parameter between the T0 and T2 periods.ConclusionCorrection of the palatal anatomy by rapid maxillary expansion therapy has a beneficial effect on both improvements in hearing and normal function of the middle ear in both non-cleft and bilateral cleft lip palate patients. Similarly, rapid maxillary expansion significantly influences voice quality in non-cleft patients, with no significant effect in BCLP patients.

Project description:BackgroundCurrently available local anesthetics approved for single-injection peripheral nerve blocks have a maximum duration of <24 hours. A liposomal bupivacaine formulation (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), releasing bupivacaine over 96 hours, recently gained Food and Drug Administration approval exclusively for wound infiltration but not peripheral nerve blocks.MethodsBilateral single-injection femoral nerve blocks were administered in healthy volunteers (n = 14). For each block, liposomal bupivacaine (0-80 mg) was mixed with normal saline to produce 30 mL of study fluid. Each subject received 2 different doses, 1 on each side, applied randomly in a double-masked fashion. The end points included the maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle and tolerance to cutaneous electrical current in the femoral nerve distribution. Measurements were performed from baseline until quadriceps MVIC returned to 80% of baseline bilaterally.ResultsThere were statistically significant dose responses in MVIC (0.09%/mg, SE = 0.03, 95% confidence interval [CI], 0.04-0.14, P = 0.002) and tolerance to cutaneous current (-0.03 mA/mg, SE = 0.01, 95% CI, -0.04 to -0.02, P < 0.001), however, in the opposite direction than expected (the higher the dose, the lower the observed effect). This inverse relationship is biologically implausible and most likely due to the limited sample size and the subjective nature of the measurement instruments. While peak effects occurred within 24 hours after block administration in 75% of cases (95% CI, 43%-93%), block duration usually lasted much longer: for bupivacaine doses >40 mg, tolerance to cutaneous current did not return to within 20% above baseline until after 24 hours in 100% of subjects (95% CI, 56%-100%). MVIC did not consistently return to within 20% of baseline until after 24 hours in 90% of subjects (95% CI, 54%-100%). Motor block duration was not correlated with bupivacaine dose (0.06 hour/mg, SE = 0.14, 95% CI, -0.27 to 0.39, P = 0.707).ConclusionsThe results of this investigation suggest that deposition of a liposomal bupivacaine formulation adjacent to the femoral nerve results in a partial sensory and motor block of >24 hours for the highest doses examined. However, the high variability of block magnitude among subjects and inverse relationship of dose and response magnitude attests to the need for a phase 3 study with a far larger sample size, and that these results should be viewed as suggestive, requiring confirmation in a future trial.

Dataset Information

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study.

Background

Methods

Results

Conclusions

Publications

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study.

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