drugset / Trial / NCT03618264

Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

NCT03618264 ↗

Phase 4 Completed 140 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Timeline

Start
2019-04-04
Primary completion
2019-08-15
Completion
2020-02-13

Outcome

Met primary endpoint

paper mean difference -9.3, 95% CI -13.4 to -5.1; p<0.001 PMID 33907455 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.33 mg/ml Other
Comparator Ropivacaine Other / unclassified 5 mg/ml Other

Indications

No indication recorded.