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Determine the effect of topical Bupivacaine on pain of patients undergoing craniotomy ?

Effect of Scalp Infiltration with Bupivacaine Compared with Intravenous Morphine on the postoperative pain of patients undergoing craniotomy ?

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014012513307N2
Enrollment
68
Registered
2014-02-20
Start date
2012-03-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain after surgery. Pain, unspecified

Interventions

Intervention 1: Intervention group: Bupivacaine 0.25% maximum dose of 2 mg per kilogram of patient weight. Intervention 2: Control group: Morphine 0.1 mg per kg of body weight.
Prevention
Intervention group: Bupivacaine 0.25% maximum dose of 2 mg per kilogram of patient weight
Control group: Morphine 0.1 mg per kg of body weight

Sponsors

Vice Chancellor for Research of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 149 Years

Inclusion criteria

Inclusion criteria: Major Inclusion criteria: More than 18 years of age; Undergoing elective supratentorial craniotomy surgery under general anaesthesia due to tumors or vascular lesions. Major exclusion criteria: Coronary artery disease with a contraindication to epinephrine administration; Pain due to intracranial pathology, not differentiated from post-operative pain; Addiction to alcohol and drugs; Active psychiatric illness; Chronic pain after more than 2 weeks drug use; Positive history of migraine headaches; Patient’s inability to understand or answer numeric response questions; Confirmed or potential sensitivity to topical anaesthesia; probable need for post-operative mechanical ventilation; Previous craniotomy or history of radiotherapy of the head; Pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient's pain after surgery. Timepoint: 2, 4, 6, 8, 12 and 24 hours after surgery. Method of measurement: Pain Scale Visual.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFariba Houshmandi

Ghaem Hospital

houshmandif881@mums.ac.ir+98 51 1846 5779

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026