Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After C… (NCT03618264) | Clinical Trial Compass
CompletedPhase 4
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy
China140 participantsStarted 2019-04-04
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I or II;
* Participates required to fix their head in a head clamp intraoperatively;
* Participates with an anticipated fully recovery within 2 hours postoperatively.
Exclusion Criteria:
* History of craniotomy;
* Expected delayed extubation or no plan to extubate;
* Participants who cannot use a patient-controlled analgesia (PCA) device;
* Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Allergy to opioids, dexamethasone or ropivacaine;
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
* Preoperative Glasgow Coma Scale\< 15;
* Suspicion of intracranial hypertension;
* Peri-incisional infection;
* Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested injecting dexamethasone and ropivacaine into the scalp before the craniotomy incision — is that kind of pre-emptive nerve block something that's already being used at this hospital, or is it still considered experimental?
2Since the trial measured how much sufentanil patients needed for pain relief in the 48 hours after surgery, what did the results actually show — did patients in the treatment group need significantly less opioid pain medication?
3Because this was a Phase 4 study, does that mean the drugs themselves are already well-established and the main question was just about this specific way of using them together before brain surgery?
4Post-craniotomy headache can be really debilitating — based on this trial's findings, would you consider this scalp infiltration approach as part of my pain management plan if I need a craniotomy?
5Are there any patients — based on the type of craniotomy, scalp condition, or other medications — for whom this dexamethasone and ropivacaine combination might not be appropriate or safe to discuss as an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative sufentanil consumption within 48 hours postoperatively