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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine,levobupivacaine | Experimental | 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine |
|
| levobupivacaine | Active Comparator | 20 ml of 0.5% levobupivacaine saline as a placebo |
|
| bupivacaine | Active Comparator | 20 ml of 0.5% bupivacaine saline as a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | local injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure | 220+-70 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hulya bilgin | uludag university anaesthesia and reanimation department | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8942596 | Background | 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. | |
| 11426091 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine,Levobupivacaine | 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection |
| FG001 | Levobupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection |
| FG002 | Bupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine,Levobupivacaine | 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection |
| BG001 | Levobupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Arterial Pressure | Posted | Mean | Standard Deviation | mmHg | 220+-70 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine,Levobupivacaine | 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nause, vomitting,hypertensıon | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Banu Otlar Can | uludag university | +905323827044 | botlar@hotmail.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | local injection |
|
|
| placebo | Drug | local injection |
|
|
| 15817709 | Background | 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. |
| BG002 | Bupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Levobupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection | 0 | 30 | 0 | 30 |
| EG002 | Bupivacaine | 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection | 0 | 30 | 0 | 30 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |