Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients (US-SCB)
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Purpose
Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux, September 2012.) showed significant difference in Comfort Score during Ultrasound Guided Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population. However, it is unknown whether the difference in Comfort score (1) was associated with reduction of local anesthetic (LA) volume in elderly or it is attributed to elderly population by itself. The aim of the study is to compare the Comfort score during US-SCB placement in elderly patients undergoing upper limb surgery performed with two different volumes of local anesthetics (25 ml vs 40 ml).
| Condition | Intervention |
|---|---|
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Arm Injuries Wounds and Injuries |
Procedure: Upper limb surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients |
- Comfort Score [ Time Frame: Up to average 20 min ] [ Designated as safety issue: Yes ]An independent observer unaware of the administered LA volume assessed Comfort score by evaluating maximal pain intensity resulting from block placement using a 100-mm visual analogue scale (VAS: 0, no pain-100, maximum or worst imaginable) as well as by recording any unpleasant event during block placement and by recording patient satisfaction using a four-point scale (unsatisfied, acceptable, satisfied and very satisfied).
- Block Placement Time [ Time Frame: Up to average 20 minutes ] [ Designated as safety issue: Yes ]Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Elderly (40 ml LA volume)
Population over age of 65 undergoing upper limb surgery using US-SCB receiving 40 ml of LA (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine).
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Procedure: Upper limb surgery
Elderly patients undergoing upper limb surgery received 40 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB. An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
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Experimental: Elderly (25 ml LA volume)
Population over age of 65 undergoing upper limb surgery using US-SCB receiving 25 ml of LA (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine).
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Procedure: Upper limb surgery
Elderly patients undergoing upper limb surgery received 25 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB. An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
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Detailed Description:
Involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction of LA volume for an effective US-SCB in comparison with the younger patients (2). Ultrasound-guided regional anesthesia becomes an increasingly popular technique and its performance must be as comfortable as possible. Therefore, Comfort score during block placement is extremely important. Comfort Score is consisted of maximum pain intensity (VAS), the satisfaction of the patient and the number of unpleasant events declared by the patients. It is calculated as the sum of each criterion, which was attributed a value of 0 or 1: VAS(<or=30/100, 1; >30/100, 0), number of unpleasant events (0, 1; >or=1, 0) and satisfaction (satisfied or very satisfied, 1; acceptable or unsatisfied, 0). Comfort score of 3 or 2 is considered as comfortable while score 1 or 0 as uncomfortable block placement.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age over 65 years (Elderly group)
- upper limb surgery
Exclusion Criteria:
- refusal of regional anesthesia
- any neurologic or neuromuscular disease
- clinical signs of cutaneous infection at the site of needle insertion
Contacts and Locations| Contact: Jadranka Pavičić Šarić | +385994888262 | jadranka.pavicic-saric@st.t-com.hr |
| Contact: Jelena Zenko | +385994888756 | jelena.zenko@gmail.com |
| Croatia | |
| Clinical Hospital Merkur | Recruiting |
| Zagreb, Croatia, 10000 | |
| Principal Investigator: Jadranka Pavičić Šarić | |
| Study Chair: | Matea Bogdanović Dvorščak, MD | Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care |
More Information
Publications:
| Responsible Party: | Jadranka Pavičić Šarić, Principal Investigator, Clinical Hospital Merkur |
| ClinicalTrials.gov Identifier: | NCT01624103 History of Changes |
| Other Study ID Numbers: | 2012-000261-21 |
| Study First Received: | June 16, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Croatia: Ethics Committee |
Keywords provided by Šarić, Jadranka Pavičić, M.D.:
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Arm Injuries Wounds and Injuries Lidocaine Levobupivacaine |
Bupivacaine Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Additional relevant MeSH terms:
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Arm Injuries Wounds and Injuries Anesthetics Lidocaine Levobupivacaine Bupivacaine Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013