The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

Bursa Uludag University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Bupivacaine; Drug: placebo; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02497040

uludagu

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

bupivacaine,levobupivacaine

Experimental group

Description:

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

Treatment:

Drug: Levobupivacaine

Drug: Bupivacaine

levobupivacaine

Active Comparator group

Description:

20 ml of 0.5% levobupivacaine saline as a placebo

Treatment:

Drug: Levobupivacaine

Drug: placebo

bupivacaine

Active Comparator group

Description:

20 ml of 0.5% bupivacaine saline as a placebo

Treatment:

Drug: placebo

Drug: Bupivacaine