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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 Uluda─č 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

Page last updated: August 23, 2015

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