The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block

The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02558569

Enrollment

128

Registered

2015-09-24

Start date

2015-09-30

Completion date

2016-08-31

Last updated

2016-09-14

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

Conditions

Brain Tumor

Keywords

fentanyl, scalp block

Brief summary

This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.

Detailed description

Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. The scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. In this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.

Interventions

DRUGLevobupivacaine

L form of bupivacaine with less cardiotoxicity.

OTHERNSS

Clear intravenous fluid looks alike local anesthetic.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* supratentorial brain tumor

Exclusion criteria

* tumor size\>4 cm * Glasgow Coma Score (GCS) \<15 * already intubated * uncontrolled hypertension * can not communicate

Design outcomes

Primary

Measure	Time frame	Description
The total dose of fentanyl being used during craniotomy	One day	Total dose of fentanyl use during operative period

Secondary

Measure	Time frame	Description
Awakening time from general anesthesia	One day	Time from the end of anesthetic to fully awake and extubation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026