Clinical trial NCT06720285: The Efficacy of Regional Scalp Block in Craniotomy
Official title: The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Scalp Nerve Block
Craniotomy Surgery
Keywords: Regional anesthesia
Scalp Nerve Block
Craniotomy
Surgery
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
Collaborators: name: Dr. Soetomo Hospital, Surabaya
name: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Aged \>18 years
* American Society of Anesthesiologists (ASA) classification I-III
* Glasgow Coma Scale (GCS) score ≥ 13
* Elective craniotomy

Exclusion Criteria:

- 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

Primary outcomes:
measure: Total opioid consumption
timeFrame: From enrollment until 24 hours post craniotomy surgery.
Secondary outcomes:
measure: Pain Scale
timeFrame: 0 to 24 hours after surgery
measure: Laboratory Markers
timeFrame: After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.
measure: The patients with PONV
timeFrame: 0 to 24 hour after surgery
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo Hospital, Surabaya
state: Jawa Timur
Study officials:
affiliation: Anesthesiology and Reanimation Department, Dr. Soetomo General Hospital, Universitas Airlangga, Indonesia
name: Christijogo Soemartono Waloejo, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Costello 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.
citation: Benyahia 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.
citation: Vadivelu 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.
citation: Ghai 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.
citation: Gottschalk 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.