Background The sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies.
Methods 107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis.
Results The cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0–21.3) vs 12.0 mg (IQR 8.0–22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV.
Conclusion Bilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence.
Trial registration number NCT02618993.
- facial pain
- nerve block
- pain management
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FR and MB are joint first authors.
FR and MB contributed equally.
Contributors MB, GC and P-FP designed and led the clinical trial. MB, FR, HL, JR, MDB and SG assisted with patient’s enrollment and data collection. NM, CV, CD and GC assisted with the design of the experiments. NM analyzed the clinical data. FR, GC, CD and XC drafted the first version of the manuscript. All authors edited the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The study protocol was approved by the South Mediterranean Ethics Committee I (Comité de Protection des Personnes Sud Mediterranée I, 13 May 2015, 2015-001345-88, Marseille, France), registered with ClinicalTrials.gov (first submitted 3 November 2015) and conducted according to good clinical practice guidelines, the Declaration of Helsinki (2008) and European Directive 2001/20/CE. The ethics committee was consulted for enrolling younger patients up to 15 years years old, which was authorized as from September 2016. Written and oral informed consent was obtained from all subjects before their inclusion in the study, as well as at least one legal representative for minors.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Our database can be available after request and approval of the local ethic committee.