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Recruiting NCT06993922

Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

No phase Interventional Dexmedetomidine Adjuvant Bupivacaine Scalp Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scalp block, Scalp block + Dexmedetomidine.
Who it may be relevant to
Registry conditions: Dexmedetomidine, Adjuvant, Bupivacaine, Scalp Block. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Detailed description

Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.

The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.

Interventions

  • Other Scalp block
    Patients will receive a scalp block with bupivacaine alone.
  • Other Scalp block + Dexmedetomidine
    Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Primary outcome measures

  • Cumulative postoperative morphine consumption [Time frame: 24 hours postoperatively]
Secondary outcome measures (5)
  • Mean arterial pressure [Time frame: 24 hours postoperatively]
  • Heart rate [Time frame: 24 hours postoperatively]
  • Degree of pain [Time frame: 24 hours postoperatively]
  • Time for 1st rescue analgesia [Time frame: 24 hours postoperatively]
  • Incidence of complications [Time frame: 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Undergoing supratentorial elective planned craniotomies.

Exclusion criteria

  • Patients refusal.
  • History of known allergy to the used local anesthetic or dexmedetomidine.
  • Bleeding disorders.
  • Evidence of local infection at the site of injection.
  • Emergency craniotomy.
  • Psychotic disorder.
  • Patients who will not be extubated in the operating room after surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06993922 · FMASU MS 57/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗