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
  Purpose

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.


Condition Intervention Phase
Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics
Other: Interscalene brachial plexus block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Further study details as provided by Royal Surrey County Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 92
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Volume, High Concentration 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, Low Concentration 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: Low Volume, High Concentration 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: Low Volume, Low Concentration 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374464

Contacts
Contact: Gillian Foxall, MBChB, MA 07917865767 gillianfoxall@nhs.net
Contact: Michele N Kigozi, BMedSci,BMBS 07977165224 nabakka@btinternet.com

Locations
United Kingdom
Royal Surrey County Hospital Not yet recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Sub-Investigator: Michele Kigozi, BMedSci,BMBS         
Sponsors and Collaborators
Royal Surrey County Hospital
Investigators
Principal Investigator: Gillian Foxall, MBChB, MA Royal Surrey County Hospital
  More Information

Publications:
Responsible Party: Gillian Foxall, Royal Surrey County Hospital
ClinicalTrials.gov Identifier: NCT01374464     History of Changes
Other Study ID Numbers: 11/LO/0934
Study First Received: June 14, 2011
Last Updated: June 15, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Surrey County Hospital:
Interscalene brachial plexus nerve block
Nerve block

Additional relevant MeSH terms:
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014