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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000155998
Enrollment
180
Registered
2011-02-09
Start date
2011-02-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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).

Sponsors

Dr Michael Fredrickson
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients requiring anaesthesia for shoulder surgery under the care of the principal and co-investigators.

Exclusion criteria

Exclusion criteria will include patient refusal for upper limb block, severe respiratory disease, known neuropathy involving the limb undergoing surgery, and known allergy to amide local anaesthetic drugs.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026