Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06993922

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

Led by Ain Shams University · Updated on 2025-05-30

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of dexmedetomidine as an addition to bupivacaine in scalp blocks compared to bupivacaine alone for managing pain after craniotomy surgery. This study focuses on adults aged 18 to 65 undergoing planned supratentorial craniotomies to better understand how adding dexmedetomidine might affect postoperative pain relief and physiological responses. Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist known for its potential to enhance pain control when combined with local anesthetics. Participants will be randomly assigned to one of two groups: one group will receive a scalp block with bupivacaine alone, and the other will receive a scalp block with dexmedetomidine added to bupivacaine. Both treatments are delivered in the operating room as part of the anesthesia technique before surgery. This double-blind study ensures that neither the participants nor the researchers know which treatment is given. During the study, participants will be monitored for 24 hours after surgery. Researchers will assess cumulative morphine use, heart rate, blood pressure, pain levels, time until first rescue pain medication is needed, and any complications during this period. This monitoring helps understand how the treatments affect pain management and safety after craniotomy. The total participation includes surgery and the 24-hour postoperative observation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Undergoing supratentorial elective planned craniotomies.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During surgery

Participants receive a scalp block with either bupivacaine alone or bupivacaine combined with dexmedetomidine during their craniotomy surgery.

1 visit (in-person) for surgery and block administration

Post-operative Follow-up

Duration - 24 hours postoperatively

Participants are monitored for pain management effectiveness and safety during the 24 hours following surgery.

Monitoring during hospital stay post-surgery

Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Egypt, 11591

Actively Recruiting

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Research Team

O

Omar A Khiralla, MBBCH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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