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NCT Number: NCT06993922

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

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.

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Key information

Conditions

Dexmedetomidine Adjuvant Bupivacaine Craniotomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Scalp Block Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Ahmed A Khalifa, MD

SUB_INVESTIGATOR

Hanaa M AbdAllah, MD

SUB_INVESTIGATOR

Mohamed M Hashem, MD

SUB_INVESTIGATOR

Omar A Khiralla, Master

CONTACT

[email protected]

00201095281838

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scalp block

Other

Patients will receive a scalp block with bupivacaine alone.

Other names: Bupivacaine

Scalp block + Dexmedetomidine

Other

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Other names: Bupivacaine + Dexmedetomidine

Primary outcomes

  1. Cumulative postoperative morphine consumption

    Time frame: 24 hours postoperatively

    If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 24 hours postoperatively

    Mean arterial pressure will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and postoperatively at 2, 4, 6,12, and 24 hours postoperatively.

  2. Heart rate

    Time frame: 24 hours postoperatively

    Heart rate will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and 2, 4, 6, 12, and 24 hours postoperatively.

  3. Degree of pain

    Time frame: 24 hours postoperatively

    Pain intensity will be evaluated on a 0-10 visual analog scale (VAS). The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The VAS score will be recorded at baseline (after admission to PACU), then after 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.

  4. Time for 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time for 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

  5. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as postoperative nausea and vomiting, respiratory depression, or any other complication will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Omar A Khiralla, MBBCH

CONTACT

[email protected]

00201095281838

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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