The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine
Information source: Uludag University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Levobupivacaine (Drug); Bupivacaine (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Uludag University Official(s) and/or principal investigator(s): hulya bilgin, Study Director, Affiliation: uludag university anaesthesia and reanimation department
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. Systolic, diastolic and mean
arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation and end-tidal carbon
dioxide were recorded. Postoperative pain was evaluated using a 10-cm visual analogue scale
(VAS).
Clinical Details
Official title: Effects of Scalp Block With Bupivacaine Versus Levobupivacaine on Haemodynamic Response to Head Pinning and Efficacy on Postoperative Analgesia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: change in mean arterial pressure
Secondary outcome: 10-cm visual analogue scale (VAS)change in heart rate change in diastolic arterial pressure change in systolic arterial pressure
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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. 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. 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. Epub 2005 Apr 7.
Starting date: March 2008
Last updated: July 9, 2015
|