Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients

Wounds and Injuries Clinical Trial

— US-SCB  

Official title:

Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01624103
• Other study ID #: 2012-000261-21
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2012
• Last updated: March 2, 2015
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: March 2015
• Source: Šaric, Jadranka Pavicic, M.D.
• Contact: Jadranka Pavicic Šaric
• Phone: +385994888262
• Email: jadranka.pavicic-saric[@]st.t-com.hr
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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 (20 ml vs 32 ml).

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(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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arm Injuries
• Wounds and Injuries

Intervention

Procedure:
• Upper limb surgery
Elderly patients undergoing upper limb surgery received 20 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.
• Upper limb surgery
Elderly patients undergoing upper limb surgery received 32 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.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Merkur	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Šaric, Jadranka Pavicic, M.D.

Country where clinical trial is conducted

Croatia, 

References & Publications (2)

Bloc S, Mercadal L, Garnier T, Komly B, Leclerc P, Morel B, Ecoffey C, Dhonneur G. Comfort of the patient during axillary blocks placement: a randomized comparison of the neurostimulation and the ultrasound guidance techniques. Eur J Anaesthesiol. 2010 Jul;27(7):628-33. doi: 10.1097/EJA.0b013e328333fc0a. — View Citation

Tomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 European Journal of Anaesthesiology 28:113,2011

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort Score	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).	Up to average 20 min	Yes
Secondary	Block Placement Time	Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.	Up to average 20 minutes	Yes