A comparison of continuous and one-off interscalene block for pain relief following minor shoulder surgery - for fractured clavicle.

A comparison of continuous and one -off interscalene block for pain relief following minor shoulder surgery - for fractured clavicle

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000770268

Enrollment

Registered

2009-09-04

Start date

2009-06-11

Completion date

2009-12-09

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

Continuous interscalene block (CISB) has been shown to provide better analgesia and patient satisfaction than opioids for rotator cuff surgery. Although CISB has been shown to provide better analgesia and patient satisfaction than opioids for rotator cuff repair, it is unknown whether these benefits apply to less painful procedures such as open reduction internal fixation (ORIF) clavicle. For this procedure randomized trials comparing CISB with traditional opioid analgesia have not been conducted. The purpose of the current study is to determine whether CISB provides better analgesia and patient satisfaction than traditional single shot interscalene block (the community standard) following minor shoulder procedures (ORIF clavicle). If the primary hypothesis is confirmed, this study will provide evidence supporting the use of continuous interscalene block for this surgery.

Interventions

Interscalene block A single operator Dr Michael Fredrickson (MF) will place all interscalene catheters (ISCs) in the operating room. Patients will be premedicated with oral acetaminophen 1g, diclofenac SR 75mg and omeprazole 20mg one hour before surgery. Intravenous midazolam 2mg, alfentanil 0.5mg and cephazolin 1g 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 anaesthesia depending on patient preference. ISCs will be placed using a combination of ultrasound and nerve stimulation. General anaesthesia will then be administered and ropivacaine 0.5% 0.5mL/kg to a maximum of 30 mL will be administered through the ISC. Patients with a continuous interscalene block (CISB) will then receive an ambulatory infusion of ropivacaine 0.2% at the end of surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patients undergoing elective minor shoulder surgery (open fixation for fractured clavicle) under the anaesthetic care of the principal investigator

Exclusion criteria

1. Patient refusal/inability to consent, age no limits. 2. Allergy amide local anaesthetic (LA) drugs. 3. Existing neurological disorders/neuropathy of the operative extremity. 4. Infection at site of needle puncture. 5. Severe respiratory disease. 6. Chronic opioid therapy. 7. Patients intolerant of all non-steroidal anti-inflammatory drugs (NSAIDs).

Outcome results