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Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Royal Surrey County Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Royal Surrey County Hospital
ClinicalTrials.gov Identifier:
NCT01374464
First received: June 14, 2011
Last updated: June 15, 2011
Last verified: June 2011

June 14, 2011
June 15, 2011
August 2012
February 2013   (final data collection date for primary outcome measure)
Change from baseline in Functional Vital Capacity post interscalene brachial plexus block [ Time Frame: 30 minutes after waking in post operative care unit ] [ Designated as safety issue: Yes ]
The functional vital capacity refers to the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Measuring FVC is done by spirometry.
Same as current
Complete list of historical versions of study NCT01374464 on ClinicalTrials.gov Archive Site
Quality of recovery from surgery [ Time Frame: First 24 hours post-operatively ] [ Designated as safety issue: No ]
By means of a quality of recovery questionnaire
Same as current
Not Provided
Not Provided
 
Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block
A Double Blind Randomised Control Trial Assessing Effects of Local Anaesthetic Concentration (0.5% vs 0.75%) and Volume (5mls vs 15mls) on the Respiratory Consequences of Ultrasound Guided Interscalene Brachial Plexus Nerve Block

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics
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
Other Names:
  • Levobupivicaine
  • Chirocaine
  • Active Comparator: High Volume, High Concentration
    Intervention: Other: Interscalene brachial plexus block
  • Active Comparator: High Volume, Low Concentration
    Intervention: Other: Interscalene brachial plexus block
  • Active Comparator: Low Volume, High Concentration
    Intervention: Other: Interscalene brachial plexus block
  • Active Comparator: Low Volume, Low Concentration
    Intervention: Other: Interscalene brachial plexus block

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
92
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

All patients undergoing day case shoulder surgery that would normally be managed with a nerve block for post-operative pain relief will be considered eligible for the study. Inclusion criteria are detailed below

  1. Age > 18 and < 80 years
  2. American Society of Anaesthetists (ASA) grades I - III. (ASA grade determines how 'fit' a patient is for surgery, with 1 being a normal healthy patient and 5 being a moribund patient that is not expected to survive. 'Fitter' patients are being chosen as it is felt that severe associated illness may influence our results).
  3. A composite pain score of 0 when assessed in the post anaesthetic care unit (PACU) at 30mins post-operatively. This will be required in order for the patient to be deemed to have an 'effective' nerve block and be entered into the study. Patients reporting pain at this point will be removed from the study and offered either a rescue brachial plexus block or alternative analgesia. (Published research by Riazi et al and by McNaught et al, indicates that 5mls of local anaesthetic solution is adequate for establishing an effective ISBPB in this immediate post-operative period).

Exclusion Criteria:

  1. Significant respiratory disease including Chronic Obstructive Pulmonary Disease or unstable asthma
  2. Renal or hepatic impairment
  3. Allergy to local anaesthetic
  4. Opiod tolerance (more then 30mg of morphine or its equivalent per day)
  5. Body mass index > 40
  6. Body weight < 56kg (due to potentially toxic doses of local anaesthetic drug if using higher volume of 0.75% concentration at below this weight)
Both
18 Years to 80 Years
No
Contact: Gillian Foxall, MBChB, MA 07917865767 gillianfoxall@nhs.net
Contact: Michele N Kigozi, BMedSci,BMBS 07977165224 nabakka@btinternet.com
United Kingdom
 
NCT01374464
11/LO/0934
No
Gillian Foxall, Royal Surrey County Hospital
Royal Surrey County Hospital
Not Provided
Principal Investigator: Gillian Foxall, MBChB, MA Royal Surrey County Hospital
Royal Surrey County Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP