CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
The dexamethasone plus ropivacaine +1 moredrug
Likely dose
The dexamethasone plus ropivacaine 0.25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04051723
NCT04051723Phase 4Completed

Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children

Beijing Tiantan Hospital·interventional·Posted Aug 9, 2019·Updated Jul 21, 2020

In Brief

A Phase 4 clinical trial evaluating The dexamethasone plus ropivacaine and The ropivacaine for Pain, Postoperative and Children. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. 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 unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. 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. Researchers have clarified that the addition of dexamethasone to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 9, 2019
Enrollment StartSep 2, 2019
Primary CompletionJun 5, 2020
Study CompletionJul 5, 2020
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 6.9 years ago

Interventions

The dexamethasone plus ropivacainedrug

The local infiltration solution containing 0.25mg Dexamethasone and 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

The ropivacainedrug

The local infiltration solution containing 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.