Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy

NCT07788261 | Completed

• 1 other identifier: 04-2025-300572
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dexamethasone; Lidocaine; Scalp Incision Infiltration; Craniotomy

Outcome Measures

Primary Outcomes (2)

• Degree of pain

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

  48 hours postoperatively

• Total opioid consumption

  Total postoperative opioid (fentanyl) consumption was recorded.

  48 hours postoperatively

Secondary Outcomes (5)

• Mean arterial pressure

  Till the end of surgery (Up to 2 hours)

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Time to first postoperative analgesic request

  48 hours postoperatively

• Incidence of postoperative nausea and vomiting

  48 hours postoperatively

• Degree of patient satisfaction

  48 hours postoperatively

Study Arms (2)

Dexamethasone group

EXPERIMENTAL

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

Drug: Xylocaine plus Dexamethasone

Control group

ACTIVE COMPARATOR

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

Drug: Xylocaine plus epinephrine

Interventions

Xylocaine plus Dexamethasone DRUG

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

Dexamethasone group

Xylocaine plus epinephrine DRUG

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

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Dexamethasone; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Egypt

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: December 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)