Effects of Scalp Nerve Block on Postoperative Pain, Hemodynamics and Surgical Stress Response in Craniotomy Surgery

NCT ID: NCT06748547

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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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

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Analgesia Post Operative Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Group pre-incisional: received 0.5% 20 ml bupivacaine preincisional before the nail head was placed

scalp nerve block

Intervention Type PROCEDURE

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.

2

Group post-incisional: received 0.5% 20 ml bupivacaine postcisional after the skin incision was closed

scalp nerve block

Intervention Type PROCEDURE

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.

Interventions

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scalp nerve block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age range 18-65
* ASA 1-3 score

Exclusion Criteria

* Chronic hypertension
* Arrhythmia
* body mass index (BMI) over 40 kg/m2
* Bleeding diathesis
* Allergy
* Serious cardiovascular, pulmonary, renal and hepatic disease
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zeliha Alicikus

Head of Anesthesia and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Umraniye Education and Research Hospital

Istanbul, Umraniye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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UERH-AR-ZT-10

Identifier Type: -

Identifier Source: org_study_id

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