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The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

Effects of Scalp Block With Bupivacaine Versus Levobupivacaine on Haemodynamic Response to Head Pinning and Efficacy on Postoperative Analgesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02497040
Enrollment
90
Registered
2015-07-14
Start date
2008-03-31
Completion date
2009-04-30
Last updated
2018-01-05

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

Conditions

Hypertension

Keywords

anaesthesia, local anaesthesia, hemodynamics, bupivacaine, levobupivacaine

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).

Detailed description

Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ University, (the date and protocol number assigned by this ethics committee were March 4, 2008 and 5/30, respectively),written informed consent was obtained from patients undergoing elective scheduled operations involving craniotomy during anaesthesia consultations. Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I or II patients of either sex between 18-85 years of age were allocated to this randomised, prospective, placebo-controlled, double-blind study. The patients were randomly divided into three groups using a sealed-enveloped technique 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)). Twenty-millilitre syringes for the block were prepared and numbered by a blinded assistant.

Interventions

DRUGLevobupivacaine

local injection

DRUGBupivacaine

local injection

DRUGplacebo

local injection

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in Mean Arterial Pressure220+-70 minutes

Participant flow

Participants by arm

ArmCount
Bupivacaine,Levobupivacaine
20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection
30
Levobupivacaine
20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection
30
Bupivacaine
20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection
30
Total90

Baseline characteristics

CharacteristicBupivacaine,LevobupivacaineLevobupivacaineBupivacaineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants4 Participants3 Participants12 Participants
Age, Categorical
Between 18 and 65 years
25 Participants26 Participants27 Participants78 Participants
Region of Enrollment
Turkey
30 participants30 participants30 participants90 participants
Sex: Female, Male
Female
15 Participants19 Participants19 Participants53 Participants
Sex: Female, Male
Male
15 Participants11 Participants11 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 300 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 300 / 30

Outcome results

Primary

Change in Mean Arterial Pressure

Time frame: 220+-70 minutes

ArmMeasureValue (MEAN)Dispersion
Bupivacaine,LevobupivacaineChange in Mean Arterial Pressure110 mmHgStandard Deviation 20
LevobupivacaineChange in Mean Arterial Pressure105 mmHgStandard Deviation 20
BupivacaineChange in Mean Arterial Pressure100 mmHgStandard Deviation 20

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