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Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block

NCT01374464 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-06-16

No results posted yet for this study

Summary

Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics (morphine) to control pain. Morphine has numerous unwanted side effects including sedation, hallucinations and vomiting.

It is now standard procedure for patients undergoing shoulder surgery to have their pain controlled by means of an injection made around the nerves where they pass through the neck to supply the shoulder with sensation (similar to the numbing injections made by the dentist before a dental procedure). This injection is called a 'nerve block'.

Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to discharge patients home on the day of surgery, pain free and with no opiate side effects. However, a side effect of nerve blocks at this level is involvement of the phrenic nerve, which is anatomically close to the injection point. This may cause (temporary) paralysis of the diaphragm and in some cases, severe respiratory dysfunction.

Research shows that reducing either the volume or the concentration of the drug injected, can reduce the consequent respiratory dysfunction. However no study has compared both volume and concentration in parallel, to see which of these has the more significant effect in reducing respiratory dysfunction. Furthermore there has been no assessment of how these changes may affect the duration of analgesia received and patient coping after discharge.

The investigators propose to conduct a double blind randomised controlled trial at the Royal Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic (key hole) surgery over a period of 6 months. Patients will receive one of four treatment allocations:

1. Low concentration-high volume of local anaesthetic
2. Low concentration-low volume of local anaesthetic
3. High concentration-high volume of local anaesthetic
4. High concentration-low volume of anaesthetic drug of local anaesthetic.

The aim of this study is to inform an optimum dosing regimen for patients in order to facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.

Conditions

  • Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics

Interventions

OTHER

Interscalene brachial plexus block

4 different administrations of levobupivicaine will be applied: 1. High Volume, High Concentration = 15mls of 0.75% levobupivicaine 2. High Volume, Low Concentration = 15mls of 0.5% levobupivicaine 3. Low Volume, High Concentration = 5mls of 0.75% levobupivicaine 4. Low Volume, Low Concentration = 5mls of 0.5% levobupivicaine

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Gillian Foxall, MBChB, MA · Royal Surrey County Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374464 on ClinicalTrials.gov