AnalgesiaNCT06748547
Effects of Scalp Nerve Block on Postoperative Pain, Hemodynamics and Surgical Stress Response in Craniotomy Surgery
An observational study of Analgesia and Post Operative Pain, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The hypothesis of this study is that preincisional scalp nerve block will reduce postoperative opioid use and surgical stress response compared to postincisional scalp nerve block in craniotomy surgery with general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Post Operative Pain
- What is being tested?
- scalp nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 1 May 2026
- Phase
- Observational
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo cranitomy with general anesthesia
Who may be able to join
- Age range 18-65
- ASA 1-3 score
Who cannot join
- Chronic hypertension
- Arrhythmia
- body mass index (BMI) over 40 kg/m2
- Bleeding diathesis
- Allergy
- Serious cardiovascular, pulmonary, renal and hepatic disease
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- Local infection at the injection site
- Alcohol and substance abuse
- Neurological sequelae, mental retardation
- GCS under 15
- Patients admitted to the intensive care unit as intubated
- Pregnancy
- Those with a history of chronic pain
- Scalp infection
- Use of vozoactive drugs
- Patients with previous craniotomy
- Patients who do not accept
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34734
About this study
Official title: Effects of Scalp Nerve Block on Postoperative Pain, Hemodynamics and Surgical
The hypothesis of this study is that preincisional scalp nerve block will reduce postoperative opioid use and surgical stress response compared to postincisional scalp nerve block in craniotomy surgery with general anesthesia.
Read the detailed description
Craniotomy is an effective treatment method for cerebral diseases and injuries, and postoperative pain is an important clinical problem. The most painful stages of craniotomy are the placement of a nail head and skin incision. Therefore, in these stages, it is necessary to increase the depth of anesthesia with additional analgesic administration to prevent hemodynamic responses such as tachycardia and hypertension. In patients with impaired cerebral autoregulation, a sudden increase in systemic blood pressure can cause a sudden increase in intracranial pressure, which accelerates intracranial hypertension. High oxygen consumption and catecholamine release caused by postoperative pain can lead to increased cerebral perfusion and increased intracranial pressure, which can predispose to intracranial hematoma. Effective postoperative pain management is important to prevent these systemic changes, improve rehabilitation, and improve long-term outcomes.
In addition, early postoperative pain management can prevent the development of central sensitization and chronic pain caused by surgical tissue damage.
In recent years, studies aimed at controlling postoperative pain starting from the preoperative period have brought the concept of preemptive analgesia to the agenda. Preemptive analgesia is applied before the painful stimulus in order to reduce the pain. Studies have suggested that surgical trauma causes an increase in nociceptive afferent transmission and causes changes in the excitation threshold in both peripheral and central neurons, and it is thought that postoperative pain can be controlled by preoperative blockade of this mechanism. Multimodal analgesia includes the use of single agents in postoperative pain control, especially the use of different pain control mechanisms to reduce the opioid dose, improve the analgesic effect and minimize the risk of side effects.
Scalp nerve block (SSB) is widely used to reduce hemodynamic response and incisional pain during craniotomy. Analgesia can be achieved by blocking the greater and lesser occipital nerves, supraorbital and supratrochlear nerves, zygomatico-temporal nerve, auriculo-temporal nerve and greater auricular nerve. SBB is combined with non-opioid drugs with different mechanisms of action to maximize the analgesic effect. Traumatic stimulation, such as surgery, acts on peripheral nerve pain receptors and produces nerve impulses that are transmitted to spinal dorsal horn neurons via Aδ and C fibers, and pain occurs after loading and integration. SSB can interrupt this pathway. Effective postoperative analgesia can reduce complications and mortality.
- Conditions
- Analgesia, Post Operative Pain
- Being tested
- scalp nerve block
- Keywords
- scalp nerve block,Craniotomy,postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp nerve blockProcedure or surgery
scalp nerve block is performed bilaterally by an anesthesiologist after induction of anesthesia and 5 minutes before head immobilization, according to the technique described by Pinosky et al. Prepare a syringe (20 mL) for scalp blocks. It is performed using 0.35% bupivacaine and 5 mcg epinephrine (1:2,000,000) using a 23-gauge needle inserted at a 45° angle to the skin and penetrating deeply into the outer edge of the scalp.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group pre-incisional: received 0.5% 20 ml bupivacaine preincisional before the nail head was placed Receives: Procedure: scalp nerve block | |
| 2 | Group post-incisional: received 0.5% 20 ml bupivacaine postcisional after the skin incision was closed Receives: Procedure: scalp nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic parameters
mean arterial pressure (mmHg)
Measured: 24 hours
Secondary outcomes (1)
amount of opioid received during surgery
remifentanil total dosage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Nov 2025
- Primary completion28 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748547
- Sponsor's protocol ID
- UERH-AR-ZT-10
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No