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Effect of orifice configuration on the effectiveness of continuous peripheral nerve blockade

Effect of orifice configuration on the effectiveness of continuous peripheral nerve blockade in patients having shoulder surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000114842
Acronym
N/A
Enrollment
150
Registered
2012-01-24
Start date
2012-01-24
Completion date
2012-12-13
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 3 different orifice configurations for perineural catheters administered for nerve block for pain relief after shoulder surgery. We will be primarily assessing the frequency of pain in recovery. 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). 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 (Fredrickso

An experienced operator will place all interscalene catheters (ISCs). 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). Patients will then be randomised (using a computerised random number generator) to an single hole, triple hole or 6 hole perineural catheter. 15 mL ropivacaine 0.375% will be administered via the catheter. At the end of surgery under general anaesthesia, an ambulatory infusion of ropivacaine 0.2% at 2 mL/h with PRN “on demand” 5 mL boluses. 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