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Completed

NCT Number: NCT07788261

Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy

This study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy.

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Key information

Conditions

Dexamethasone Craniotomy Lidocaine Scalp Incision Infiltration

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

About this study

Approximately 55-87% of patients undergoing craniotomy experience moderate to severe pain during the first 48 hours after surgery, which negatively influences their postoperative rehabilitation.

Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries.

To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age between 20 and 60 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II
  • Scheduled for elective supratentorial tumor craniotomy under general anesthesia.

Exclusion criteria

  • Patients with known hypersensitivity to lidocaine or dexamethasone.
  • Chronic corticosteroid therapy.
  • Pre-existing coagulopathy.
  • Significant hepatic or renal impairment.

Treatment and study plan

Xylocaine plus Dexamethasone

Drug

Patients received the incision site infiltration of 2% xylocaine plus dexamethasone.

Xylocaine plus epinephrine

Drug

Patients received the incision site infiltration of 2% xylocaine plus epinephrine.

Primary outcomes

  1. Degree of pain

    Time frame: 48 hours postoperatively

    Degree of pain was measured using the Numerical Rating Scale after surgery (numeric rating scale (NRS); 0 = no pain, 10 = worst imaginable pain)

  2. Total opioid consumption

    Time frame: 48 hours postoperatively

    Total postoperative opioid (fentanyl) consumption was recorded.

Secondary outcomes

  1. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 2 hours)

    Mean arterial pressure was measured during induction and every fifteen minutes after that.

  2. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate was measured during induction and every fifteen minutes after that

  3. Time to first postoperative analgesic request

    Time frame: 48 hours postoperatively

    The time to the first postoperative analgesic request was recorded from the end of surgery till the first dose of fentanyl administered.

  4. Incidence of postoperative nausea and vomiting

    Time frame: 48 hours postoperatively

    Incidence of postoperative nausea and vomiting was recorded.

  5. Degree of patient satisfaction

    Time frame: 48 hours postoperatively

    Degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

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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