Craniotomy SurgeryPhase 4NCT04749797
Cranial Blocks for Postoperative Anesthesia
A Phase 4 study testing Liposomal bupivacaine, Bupivacaine Injection and Saline in people with Craniotomy Surgery, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy Surgery
- What is being tested?
- Liposomal bupivacaine, Bupivacaine Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 20 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Need for elective supratentorial craniotomy
- Preoperative GCS > 13
Who cannot join
- Preoperative GCS ≤ 13
- Child (<18 years of age)
- Inability to understand or use the visual analog scale (VAS)
- Proven or suspected allergy to local anesthetics
- Craniotomy incision extending beyond the field of the block
- Patients chronically (more than 2 wk) treated with narcotic medications
Show all 13Show fewer
- Previous scalp incision
- Bilateral craniotomies
- Allergies to local anesthetics
- GCS verbal score < 4 after extubation
- Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
- Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
- Lactating Mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
Read the detailed description
Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.
The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.
- Conditions
- Craniotomy Surgery
- Being tested
- Liposomal bupivacaine, Bupivacaine Injection, Saline
- Keywords
- craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Used as cranial block for craniotomy surgery
Bupivacaine InjectionDrug
Used as cranial block for craniotomy surgery
SalineDrug
Used as cranial block for craniotomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Placebo comparator | The surgeon will administer injectable saline as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. Receives: Drug: Saline |
| Bupivacaine | Active comparator | The surgeon will administer bupivacaine as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. Receives: Drug: Bupivacaine Injection |
| Liposomal Bupivacaine | Experimental | The surgeon will administer Exparel (liposomal bupivacine) as a cranial block. 20 mL of Exparel will be diluted with saline to constitute 60 mL total. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The Visual Analogue Scale (VAS) is a straight, horizontal line of fixed length, numbered 0 to 10 as a measure of pain severity. The ends are the extreme limits of this scale, with the left side (0) representing the best outcome (no pain), and the right side (10) representing the worst outcome, extreme pain. The other numbers in between are representations of the variation in pain between these two feelings. The scale is presented to the participant with a verbal explanation of its meaning, and the participant points to or states a number indicating where they feel their pain level is best represented on the scale. That number is recorded.
For each group, every participant reported several different pain scores over multiple hours. The averages (means) below represent the summation of all of the pain scores reported throughout their admission.
Measured: 10 months (study terminated prior to completion)
Secondary outcomes (1)
Length of Stay (ICU and
The secondary outcome variables are the duration of stay in the intensive care unit (ICU), and the duration of time in the hospital until discharge.
Measured: 10 months (study terminated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start2 Sep 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Craniotomy SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Lucas, MD, PHD, MHCI, University of Pennsylvania
- Investigators
- Timothy H Lucas, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749797
- Sponsor's protocol ID
- 834603
- Status last verified
- Aug 2023
- First submitted
- 11 Jan 2021
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan at this time to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage
- ClinicalTrials.gov ID
- NCT04749797
- Acronym / sponsor ID
- 834603
- Conditions
- Craniotomy Surgery
- Keywords
- craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
Detailed description
Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.
The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
| Arm | Type | Receives |
|---|---|---|
| Saline group | Placebo comparator | Drug: SalineThe surgeon will administer injectable saline as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. |
| Bupivacaine | Active comparator | Drug: Bupivacaine InjectionThe surgeon will administer bupivacaine as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. |
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaineThe surgeon will administer Exparel (liposomal bupivacine) as a cranial block. 20 mL of Exparel will be diluted with saline to constitute 60 mL total. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- Need for elective supratentorial craniotomy
- Preoperative GCS > 13
Key exclusion criteria (13 listed)
- Preoperative GCS ≤ 13
- Child (<18 years of age)
- Inability to understand or use the visual analog scale (VAS)
- Proven or suspected allergy to local anesthetics
- Craniotomy incision extending beyond the field of the block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineUsed as cranial block for craniotomy surgery | Drug | Liposomal Bupivacaine |
| Bupivacaine InjectionUsed as cranial block for craniotomy surgery | Drug | Bupivacaine |
| SalineUsed as cranial block for craniotomy surgery | Drug | Saline group |
Primary outcome
Visual Analogue Scale
Time frame: 10 months (study terminated prior to completion)
The Visual Analogue Scale (VAS) is a straight, horizontal line of fixed length, numbered 0 to 10 as a measure of pain severity. The ends are the extreme limits of this scale, with the left side (0) representing the best outcome (no pain), and the right side (10) representing the worst outcome, extreme pain. The other numbers in between are representations of the variation in pain between these two feelings. The scale is presented to the participant with a verbal explanation of its meaning, and the participant points to or states a number indicating where they feel their pain level is best represented on the scale. That number is recorded. For each group, every participant reported several different pain scores over multiple hours. The averages (means) below represent the summation of all of the pain scores reported throughout their admission.
1 secondary outcome
Length of Stay (ICU and
Time frame: 10 months (study terminated)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. No plan at this time to share data with other researchers.
Related trials for Craniotomy Surgery
Not yet recruiting
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
Craniotomy Surgery
Recruiting
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Brain Tumor, Brain Cancer
Not yet recruitingObservational study
Real Time Craniotomy Planning Using Mixed Reality
Neurosurgery, Surgical Planning
RecruitingObservational study
Blood Viscosity and Outcomes After Elective Craniotomy
Postoperative Complications, Intracranial Surgery
Not yet recruitingPhase 3
Echo-guided Scalp Blocks and Incidence of Postoperative Pain in Scheduled Supratentorial Intracranial Surgery.
Anesthesia , Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy H Lucas, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine, Bupivacaine Injection and Saline in people with Craniotomy Surgery, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 10 months (study terminated prior to completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.