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

November 16, 2025 updated by: Zeliha Alicikus, Umraniye Education and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Umraniye
      • Istanbul, Umraniye, Turkey (Türkiye), 34734
        • Umraniye Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo cranitomy with general anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Group pre-incisional: received 0.5% 20 ml bupivacaine preincisional before the nail head was placed
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic parameters
Time Frame: 24 hours
mean arterial pressure (mmHg)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of opioid received during surgery
Time Frame: 24 hours
remifentanil total dosage
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

March 28, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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