Scalp Nerve BlockEarly Phase 1NCT06720285
The Efficacy of Regional Scalp Block in Craniotomy
A Early Phase 1 study testing nerve block with 0.5% ropivacaine and General anesthesia and opioids (fentanyl, propofol, rocuronium) in people with Scalp Nerve Block and Craniotomy Surgery, run by Universitas Airlangga at 1 site in Indonesia.
Trial summary
The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Scalp Nerve Block, Craniotomy Surgery
- What is being tested?
- nerve block with 0.5% ropivacaine and General anesthesia and opioids (fentanyl, propofol, rocuronium)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 30 Nov 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18 years
- American Society of Anesthesiologists (ASA) classification I-III
- Glasgow Coma Scale (GCS) score ≥ 13
- Elective craniotomy
Who cannot join
- Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery
The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.
- Conditions
- Scalp Nerve Block, Craniotomy Surgery
- Being tested
- nerve block with 0.5% ropivacaine, General anesthesia and opioids (fentanyl, propofol, rocuronium)
- Keywords
- Regional anesthesia, Scalp Nerve Block, Craniotomy, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block with 0.5% ropivacaineProcedure or surgery
Compared to active comparator arm, the experimental arm received the same procedure except in the analgesia maintenance which was performed by nerve block of the scalp using 0.5% ropivacaine. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.
General anesthesia and opioids (fentanyl, propofol, rocuronium)Drug
Compared to experimental arm, the active comparator arm received the same procedure except in the analgesia maintenance which was performed through continuous fentanyl infusion. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment with Scalp Nerve Block | Experimental | General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine.
During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia. Receives: Procedure: nerve block with 0.5% ropivacaine; Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium) |
| Standard Treatment | Active comparator | General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Then, continuous fentanyl infusion as analgesia maintenance as the standard treatment. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia. Receives: Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg.
Measured: From enrollment until 24 hours post craniotomy surgery.
Secondary outcomes (3)
Pain Scale
Pain scale was assessed using the Critical-care Pain Observational Tool (CPOT) every 4 hours
Measured: 0 to 24 hours after surgery
Laboratory Markers
Laboratory markers measured were Interleukin (IL)-6 (pg/mL), Tumor Necrosis Factor (TNF)-α (pg/mL), prostaglandin E2 (PGE2) (pg/mL), cortisol level (μg/dL), blood glucose level (mg/dL), neutrophil count (cells/μL), lymphocyte count (cells/μL) and neutrophil-to-lymphocyte ratio (NLR).
Measured: After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.
The patients with PONV
Postoperative nausea and vomiting
Measured: 0 to 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Scalp Nerve BlockStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Soetomo Hospital, Surabaya, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
- Responsible party
- Principal investigator, Dr. Christijogo Soemartono Waloejo, Universitas Airlangga
- Investigators
- Christijogo Soemartono Waloejo, MD, Ph.D, Principal investigator, Anesthesiology and Reanimation Department, Dr. Soetomo General Hospital, Universitas Airlangga, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720285
- Sponsor's protocol ID
- IRB: 0769/KEPK/IX/2023
- Other IDs
- INA-XOYLZRE
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual data may be requested through formal and reasonable request. This must be adressed to the principal investigator, and the decision is at his discretion.
Publications
Chen Y, Ni J, Li X, Zhou J, Chen G. Scalp block for postoperative pain after craniotomy: A meta-analysis of randomized control trials. Front Surg. 2022 Sep 26;9:1018511. doi: 10.3389/fsurg.2022.1018511. eCollection 2022.
PubMed 36225222Costello TG, Cormack JR. Anaesthesia for awake craniotomy: a modern approach. J Clin Neurosci. 2004 Jan;11(1):16-9. doi: 10.1016/j.jocn.2003.09.003. No abstract available.
PubMed 14642359Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.
PubMed 28913452Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016.
PubMed 26929661Ghai B, Jafra A, Bhatia N, Chanana N, Bansal D, Mehta V. Opioid sparing strategies for perioperative pain management other than regional anaesthesia: A narrative review. J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):3-10. doi: 10.4103/joacp.JOACP_362_19. Epub 2022 Feb 4.
PubMed 35706649Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
PubMed 17410701
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery
- ClinicalTrials.gov ID
- NCT06720285
- Acronym / sponsor ID
- IRB: 0769/KEPK/IX/2023
- Conditions
- Scalp Nerve Block, Craniotomy Surgery
- Keywords
- Regional anesthesia, Scalp Nerve Block, Craniotomy, Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Collaborators
- Dr. Soetomo Hospital, Surabaya, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment with Scalp Nerve Block | Experimental | Procedure: nerve block with 0.5% ropivacaine, Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia. |
| Standard Treatment | Active comparator | Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Then, continuous fentanyl infusion as analgesia maintenance as the standard treatment. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >18 years
- American Society of Anesthesiologists (ASA) classification I-III
- Glasgow Coma Scale (GCS) score ≥ 13
- Elective craniotomy
Key exclusion criteria (1 listed)
- Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration
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 |
|---|---|---|
| nerve block with 0.5% ropivacaineCompared to active comparator arm, the experimental arm received the same procedure except in the analgesia maintenance which was performed by nerve block of the scalp using 0.5% ropivacaine. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia. | Procedure or surgery | Standard Treatment with Scalp Nerve Block |
| General anesthesia and opioids (fentanyl, propofol, rocuronium)Compared to experimental arm, the active comparator arm received the same procedure except in the analgesia maintenance which was performed through continuous fentanyl infusion. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia. | Drug | Standard Treatment, Standard Treatment with Scalp Nerve Block |
Primary outcome
Total opioid consumption
Time frame: From enrollment until 24 hours post craniotomy surgery.
Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg.
3 secondary outcomes
Pain Scale
Time frame: 0 to 24 hours after surgery
Laboratory Markers
Time frame: After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.
The patients with PONV
Time frame: 0 to 24 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 36225222Chen Y, Ni J, Li X, Zhou J, Chen G. Scalp block for postoperative pain after craniotomy: A meta-analysis of randomized control trials. Front Surg. 2022 Sep 26;9:1018511. doi: 10.3389/fsurg.2022.1018511. eCollection 2022.
- Background: PubMed 14642359Costello TG, Cormack JR. Anaesthesia for awake craniotomy: a modern approach. J Clin Neurosci. 2004 Jan;11(1):16-9. doi: 10.1016/j.jocn.2003.09.003. No abstract available.
- Background: PubMed 28913452Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.
- Background: PubMed 26929661Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016.
- Background: PubMed 35706649Ghai B, Jafra A, Bhatia N, Chanana N, Bansal D, Mehta V. Opioid sparing strategies for perioperative pain management other than regional anaesthesia: A narrative review. J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):3-10. doi: 10.4103/joacp.JOACP_362_19. Epub 2022 Feb 4.
- Background: PubMed 17410701Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
- Individual participant dataSharing planned: Undecided. The individual data may be requested through formal and reasonable request. This must be adressed to the principal investigator, and the decision is at his discretion.
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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.
Christijogo Soemartono Waloejo, MD, Ph.D principal investigator
Anesthesiology and Reanimation Department, Dr. Soetomo General Hospital, Universitas Airlangga, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing nerve block with 0.5% ropivacaine and General anesthesia and opioids (fentanyl, propofol, rocuronium) in people with Scalp Nerve Block and Craniotomy Surgery, run by Universitas Airlangga at 1 site in Indonesia.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2024. 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 Indonesia. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total opioid consumption (time frame: From enrollment until 24 hours post craniotomy surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06720285, which also lists 6 linked publications.
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 6 Dec 2024.