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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06748547
Study groupRoleWhat they receive
1Group pre-incisional: received 0.5% 20 ml bupivacaine preincisional before the nail head was placed
Receives: Procedure: scalp nerve block
2Group 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.

  1. hemodynamic parameters

    mean arterial pressure (mmHg)

    Measured: 24 hours

Secondary outcomes (1)
  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.

  1. First posted27 Dec 2024
  2. Study start30 Nov 2025
  3. Primary completion28 Mar 2026
  4. Study completion1 May 2026

Resources

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)
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

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