Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial

Abstract

IntroductionPre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children.Methods and analysisThe RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8–18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle.Ethical approval and disseminationThe study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals.Trial registration numberNCT03636165; Pre-results.

A Clinical Research on the Impact of Dexamethasone Versus Dexamethasone-Metoclopramide Combination in Reducing Postoperative Vomiting and Nausea After Cranial Surgery

“…However, earlier dexamethasone was taken by patients after chemotherapy to reduce the chances of motion sickness, vomiting, and nausea. A new study gained attention when steroids were used for these adverse effects [ 9 ]. Steroids tend to become a threat to immunity and due to their high-intensity dose, it was reconsidered when using as an antiemetic drug [ 10 , 11 ].…”

Postcraniotomy Headache: Etiologies and Treatments

“…There are studies evaluating the efficacy of ropivacaine for local scalp nerve blocks in the paediatric population, but there are still no results [59]. Other trials are assessing potential benefits of adding prednisolone to preemptive local ropivacaine scalp infiltrations [60]. There seems to be a local anti-inflammatory and anti-swelling effect without an oncogenic effect on glioblastomas [27 •, 28] of orally applied glucocorticoids such as dexamethasone [26] (Tables 1 and 2).…”