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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
  1. Chunmei Zhao1,
  2. Yitong Jia1,
  3. Zipu Jia1,
  4. Xiong Xiao2,
  5. Fang Luo3
  1. 1 Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  2. 2 Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  3. 3 Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  1. Correspondence to Professor Fang Luo; luofangwt{at}yahoo.com

Abstract

Introduction Pre-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 analysis The 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 dissemination The 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 number NCT03636165; Pre-results.

  • scalp infiltration
  • methylprednisolone
  • postoperative pain
  • randomized controlled trial
  • protocol

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors CZ and YJ contributed equally to this work and should be considered co-first authors. CZ and YJ contributed to the conception and drafting of the first manuscript for this trial. FL is the principal investigator of the entire study and edited the final manuscript. ZJ and XX contributed to the conception of the research protocol and will participate in the follow-up for this trial. All authors critically revised and modified the protocol and the article. They all approved the final version to be published.

  • Funding This study was funded by Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (No. XMLX201707).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Substantive protocol amendments will be reported, reviewed and approved by the local medical ethical committee before application. The frequency of monitoring visits will be determined by the site enrolment rate. Rules on publication will follow international recommendations.

  • Patient consent for publication Obtained.

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