- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07049094
Study Comparing Two Pain Relief Methods After Brain Surgery
This important clinical trial compares two different approaches to managing pain after brain surgery (craniotomy). The study focuses on patients undergoing elective cranial surgery for conditions like brain tumors or cerebrovascular diseases. Researchers want to determine whether a newer formulation of pain medication (liposomal bupivacaine) works better than the standard version (hydrochloride bupivacaine) when used in scalp nerve blocks.
The study will include 218 adult patients who will be randomly assigned to one of two groups: one receiving the standard pain medication and the other receiving the new formulation. Neither patients nor most medical staff will know which treatment each patient receives (single-blind design), helping ensure unbiased results.
Before surgery, all participants will undergo thorough health assessments including neurological exams, blood tests, and heart function tests. During surgery, all patients will receive carefully controlled anesthesia. The key difference comes in the nerve block procedure performed before the surgical incision – this is where the different pain medications will be tested.
After surgery, researchers will carefully monitor patients' pain levels at regular intervals using standard pain rating scales. They'll track not just pain at rest, but also pain during activities like coughing. The study will also evaluate recovery quality, medication needs, and any side effects for five days after surgery.
This research is particularly important because brain surgery can cause significant postoperative pain, but pain management must be carefully balanced with the need to monitor neurological function. Finding safer, longer-lasting pain control methods could greatly improve patient comfort and recovery. The liposomal formulation being tested may provide longer pain relief with fewer side effects than current options.
For patients considering participation or their caregivers, it's important to note the strict eligibility criteria. The study excludes people with certain pre-existing conditions, medication allergies, or cognitive impairments that might affect pain reporting. Participants must be able to understand and use the pain rating scales.
Potential benefits include close monitoring of pain and recovery, while risks may include typical side effects of nerve blocks or the medications used. The study includes careful safety monitoring and procedures to address any complications that might arise.
This type of research contributes valuable information that helps doctors provide better pain management for future patients. By comparing these two approaches in a rigorous scientific manner, the study aims to determine whether the newer medication offers meaningful advantages in terms of pain control duration, effectiveness, or safety profile.
For anyone facing brain surgery, understanding pain management options is crucial. This study represents an important step in refining postoperative care protocols to maximize patient comfort while minimizing risks and side effects. The results could influence future standard practices in neurosurgical pain management.
Patients interested in participating should discuss with their healthcare providers to determine if they meet the study criteria and whether joining a clinical trial is appropriate for their individual situation. Clinical trials like this one help advance medical knowledge while providing participants with access to potentially improved treatments under carefully monitored conditions.