NCT02497040

Brief Summary

Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II patients were recruited for a randomised, placebo-controlled, double-blind study and were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B; n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30). Scalp block was performed 5 min before head pinning. The primary outcome of the study was mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain was evaluated using a 10-cm visual analogue scale (VAS).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 5, 2018

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

July 2, 2015

Results QC Date

May 15, 2016

Last Update Submit

December 7, 2017

Conditions

Hypertension

Keywords

anaesthesialocal anaesthesiahemodynamicsbupivacainelevobupivacaine

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Arterial Pressure

    220+-70 minutes

Study Arms (3)

bupivacaine,levobupivacaine

EXPERIMENTAL

20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine

Drug: LevobupivacaineDrug: Bupivacaine

levobupivacaine

ACTIVE COMPARATOR

20 ml of 0.5% levobupivacaine saline as a placebo

Drug: LevobupivacaineDrug: placebo

bupivacaine

ACTIVE COMPARATOR

20 ml of 0.5% bupivacaine saline as a placebo

Drug: BupivacaineDrug: placebo

Interventions

LevobupivacaineDRUG

local injection

Also known as: chirocaine
bupivacaine,levobupivacainelevobupivacaine
BupivacaineDRUG

local injection

Also known as: marcaine
bupivacainebupivacaine,levobupivacaine
placeboDRUG

local injection

Also known as: saline
bupivacainelevobupivacaine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) Physical Status classification system 1-2

You may not qualify if:

  • Uncontrolled hypertension, arrhythmia, diabetes mellitus or coagulopathy, coronary artery disease or a proven or suspected allergy to bupivacaine or levobupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.

    PMID: 8942596BACKGROUND

  • Agarwal A, Sinha PK, Pandey CM, Gaur A, Pandey CK, Kaushik S. Effect of a subanesthetic dose of intravenous ketamine and/or local anesthetic infiltration on hemodynamic responses to skull-pin placement: a prospective, placebo-controlled, randomized, double-blind study. J Neurosurg Anesthesiol. 2001 Jul;13(3):189-94. doi: 10.1097/00008506-200107000-00002.

    PMID: 11426091BACKGROUND

  • Costello TG, Cormack JR, Mather LE, LaFerlita B, Murphy MA, Harris K. Plasma levobupivacaine concentrations following scalp block in patients undergoing awake craniotomy. Br J Anaesth. 2005 Jun;94(6):848-51. doi: 10.1093/bja/aei135. Epub 2005 Apr 7.

    PMID: 15817709BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

LevobupivacaineBupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr.Banu Otlar Can
Organization
uludag university
botlar@hotmail.com
+905323827044

Study Officials

  • hulya bilgin

    uludag university anaesthesia and reanimation department

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesia and reanimation

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 14, 2015

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

January 5, 2018

Results First Posted

January 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share