Abstract
BackgroundModerate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy. In addition, the neurosurgery operation time is relatively long, but the duration of action of SNB is limited. It is generally believed that postoperative SNB is better than preoperative SNB for postoperative analgesia. However, considering the concept of preemptive analgesia, we believe that preoperative SNB may achieve a longer postoperative analgesia effect than we expected.MethodsThis trial is a single-institution, prospective, randomized, controlled, double-blind study. A total of 180 children aged between 1 and 12 years who are undergoing elective craniotomy will be randomly allocated in a 1:1:1 ratio to three groups: group B (preoperative ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group). This randomization will be stratified by age in two strata (1–6 years and 7–12 years). The primary outcome is the total consumption of sufentanil within 24 h after surgery. The secondary outcomes include assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery.DiscussionThis study is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Further aims are to compare the effects of preoperative and postoperative SNB on postoperative analgesia in order to identify whether there is a preemptive analgesic effect and determine the better time to implement SNB in pediatric patients during craniotomy.Trial registrationChinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.
Highlights
Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients
We hypothesize that ropivacaine, which is the scalp nerve block (SNB) administered in pediatric patients undergoing neurosurgery, will decrease the requirement for sufentanil and other pain medications as well as reduce postoperative pain scores
The second aim is to determine whether preoperative block or postoperative block is more suitable for postoperative pain control
Summary
Trial design and study setting This trial is a single-institution, prospective, randomized, controlled, double-blind study that is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Information on whether additional analgesics will be needed within 3 days after surgery as well as on the drug dosage and frequency and the usage of the postoperative electronic analgesia pump (including total consumption of analgesics and the number of effective compressions and invalid compressions) will be recorded. Blinding After the patient’s enrollment, the independent anesthesiologist who performs the SNB will obtain the allocation randomized schedule from computer software operation. Nurses in the PACU, Data collection and management Investigators will explain the benefits of participating in the trial to patients and their authorized surrogates before surgery. Outcome investigators will receive training on all outcome measures Nurses, children, and their authorized surrogates will be trained to use the electronic analgesia pump.
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