Peripheral nerve blocks in patients undergoing shoulder surgery

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4q45r2
• Date of registration: 13/02/2012
• Primary sponsor: Faculdade de Medicina de Botucatu - Brazil
• Public title: Peripheral nerve blocks in patients undergoing shoulder surgery
• Scientific title: A comparative study between interscalene brachial plexus block and selective suprascapular and axillary nerve block in arthroscopic shoulder surgery
• Date of first enrolment: 15/06/2010
• Target sample size: 68
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4q45r2/
• Study design: Clinical trial, two-armed, randomized, open.

Countries of recruitment

Brazil

Contacts

• Name: Norma Sueli Módolo
• Affiliation: Faculdade de Medicina de Botucatu

• Name: Norma Sueli Módolo
• Affiliation: Faculdade de Medicina de Botucatu

Key inclusion & exclusion criteria

Inclusion criteria: Candidates for arthroscopic shoulder surgery; aged between 18 and 80 years old; of either gender; of ASA physical status I or II; with a body mass index below 35 kg/m2; capable of understanding the visual analogue pain scale; and with no medical allergies
Exclusion criteria: Patients who do not accepted participate in the study

Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Arthroscopic Surgery
E01.370.388.250.070

M00-M99

Intervention(s)

Patients will be randomly assigned to two groups, with thirty people in each group:
GI - 30 patients undergoing interscalene blockade by Winnie with the aid of a peripheral nerve stimulator (Stimuplex, B. Braun, Melsungen, Germany) and A50 needle (B. Braun Melsunger) and 30ml of 0.375% bupivacaine are administered with vasoconstrictor.
G II - 30 patients who underwent blockade of suprascapular and axillary nerves, also with aid of a neurostimulator A100 and needle (B. Braun Melsunger).
The intervention was conducted in only one time during the surgery.

Primary Outcome(s)

Sensory block was assessed by loss of cold sensation in the area of innervation of nerves with their use of cotton soaked in ether. Motor block was evaluated by Bromage scale grade 1 = no blocking, grade 2 = unable to abduction and external rotation of the arm, grade 3 = complete block of every shoulder, arm and forearm).
Cardiovascular parameters (heart rate and systolic and diastolic blood pressures) were measured and recorded upon arrival in the operating room (T1), every 5 minutes after the blockade after 30 minutes after the start of surgery (T2), in the wake (T3) and on discharge from the recovery room (PACU) (T4). Cardiocirculatory instability (BP and HR> 30% of baseline pressure of patients) was also considered as a criterion for postoperative failure. Analgesia was measured by visual analog scale (O-no pain, 10 - worst possible pain) at times T0 (PACU), T6 (6 h after blocking) T12 (12 hours after the lock) and T24 (24 hours after the lock).

Secondary Outcome(s)

Cardiocirculatory parameters,incidence of nausea and vomiting, motor block discomfort

Secondary ID(s)

54/2010

Source(s) of Monetary Support

Hospital Santa Izabel - Brazil

Secondary Sponsor(s)

Faculdade de Medicina de Botucatu - Brazil

Hospital Santa Izabel - Brazil