Clinical trial · Interventional
Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator decided not to go forward with the trial.
Summary
Brief summary (as posted)
Making sure the heart rate and or the blood pressure \[called hemodynamic instability\] during surgery is stable, setting up for a rapid postoperative recovery, and ensuring that patients have adequate pain relief are some of the important goals of neurosurgical anesthesia. Scalp block anesthesia \[injection of a numbing agent into the area of the scalp where the incision will be\] together with general anesthesia is used to achieve these goals. There has been some research on whether or not scalp block improves patient recovery and pain management, but the studies have not be large enough to say for certain. This is true even though scalp block is used with almost every patient that is having brain surgery. The investigators propose to determine if scalp block in combination with asleep anesthesia is better than asleep anesthesia alone in patients who are having brain surgery for tumors in the cerebral area of the brain.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia, Local | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Sodium chloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Scalp block with lidocaine and bupivacaine
- description
- * Scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine * Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.
- interventionNames
- Drug: Lidocaine
- Drug: Bupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Scalp block with saline
- description
- * Scalp block with saline * Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.
- interventionNames
- Drug: Sodium chloride
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: -\>18years of age undergoing elective craniotomy for supratentorial tumors Exclusion Criteria: * Age group \< 18 * Emergency craniotomies * Infratentorial tumors. * Patients who need intraoperative evoked potential monitoring which precludes the scalp block. * Patients with known cranial defects. * Patients who are on medications for chronic pain.
References
Publications (0)
Data not yet available