CompletedPhase 4ACTRN12611000155998

The effect of local anaesthetic volume and concentration on the duration of peripheral nerve blockade in patients having shoulder surgery


Sponsor

Dr Michael Fredrickson

Enrollment

180 participants

Start Date

Feb 10, 2011

Study Type

Interventional

Conditions

Summary

We intend to compare 5 different doses (by varying volume and concentration) of local anaesthetic administered for nerve block for pain relief after shoulder surgery. We will be primarily assessing the duration of the block as measured by the time to first pain. We will also assess the effectiveness of the pain relief, analgesic consumption, side effects and patient satisfaction.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates how different amounts and strengths of local anesthetic affect how long a nerve block lasts for shoulder surgery patients aged 16-80. People who refuse nerve blocks, have severe lung disease, nerve problems in the surgery arm, or are allergic to the anesthetic drugs cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

An experienced operator will place all interscalene catheters (ISCs). Patients will be premedicated with oral acetaminophen 1 g one hour before surgery. Intravenous midazolam 2 mg, alfentanil 0.5 mg a

An experienced operator will place all interscalene catheters (ISCs). Patients will be premedicated with oral acetaminophen 1 g one hour before surgery. Intravenous midazolam 2 mg, alfentanil 0.5 mg and cephazolin 1 g will be administered 5 min prior to interscalene catheter placement. Catheters will be placed following either the administration of a superficial cervical plexus block (SCPB) or after the induction of general anesthesia depending on patient preference. ISCs will be placed using a combination of ultrasound and nerve stimulation as previously described (Fredrickson et al. Anesthesiology 2010; 112:1374-1381, ANZCTR—12609000347268). General anesthesia will then be administered. Patients will then be randomized (using a computerised random number generator) to one of 5 bolus doses of ropivacaine: 1. 5 mL 0.75% 2. 10 mL 0.75% 3. 20 mL 0.375% 4. 20 mL 0.75% 5. 40 mL 0.375% Due to unanticipated block failure in 2 of the 5 groups (5mL/0.75% and 10mL/0.75%), as of patient I.D 130 onwards, randomisation is now to 1 of 7 groups as follows: 1 = 5mL/0.75% 2 = 5mL/0.75% 3 = 10mL/0.75% 4 = 10mL/0.75% 5 = 20mL/0.375% 6 = 20mL/0.75% 7 = 40mL/0.375% At the end of surgery, an ambulatory infusion of ropivacaine 0.2% at 2 mL/h with PRN “on demand” 5 mL boluses will be connected but the background infusion will remain clamped off. Patients will be instructed to turn it on (and to give the first bolus) as soon as they experience shoulder pain. The infusion will be continued for > 48 hours after surgery (Total duration = 2-5 days).


Locations(1)

New Zealand

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ACTRN12611000155998