Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block

NCT01374464 | Unknown Phase 4

• 1 other identifier: 11/LO/0934
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics

Keywords

Interscalene brachial plexus nerve block; Nerve block

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Functional Vital Capacity post interscalene brachial plexus block

  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.

  30 minutes after waking in post operative care unit

Secondary Outcomes (1)

• Quality of recovery from surgery

  First 24 hours post-operatively

Study Arms (4)

High Volume, High Concentration

ACTIVE COMPARATOR

Other: Interscalene brachial plexus block

High Volume, Low Concentration

ACTIVE COMPARATOR

Other: Interscalene brachial plexus block

Low Volume, High Concentration

ACTIVE COMPARATOR

Other: Interscalene brachial plexus block

Low Volume, Low Concentration

ACTIVE COMPARATOR

Other: Interscalene brachial plexus block

Interventions

Interscalene brachial plexus block OTHER

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

Also known as: Levobupivicaine, Chirocaine

High Volume, High Concentration; High Volume, Low Concentration; Low Volume, High Concentration; Low Volume, Low Concentration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 80 years
• 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).
• 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).

You may not qualify if:

• Significant respiratory disease including Chronic Obstructive Pulmonary Disease or unstable asthma
• Renal or hepatic impairment
• Allergy to local anaesthetic
• Opiod tolerance (more then 30mg of morphine or its equivalent per day)
• Body mass index \> 40
• Body weight \< 56kg (due to potentially toxic doses of local anaesthetic drug if using higher volume of 0.75% concentration at below this weight)

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (4)

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.

  PMID: 18682410 BACKGROUND

• McNaught A, Shastri U, Carmichael N, Awad IT, Columb M, Cheung J, Holtby RM, McCartney CJ. Ultrasound reduces the minimum effective local anaesthetic volume compared with peripheral nerve stimulation for interscalene block. Br J Anaesth. 2011 Jan;106(1):124-30. doi: 10.1093/bja/aeq306. Epub 2010 Nov 8.

  PMID: 21059701 BACKGROUND

• al-Kaisy AA, Chan VW, Perlas A. Respiratory effects of low-dose bupivacaine interscalene block. Br J Anaesth. 1999 Feb;82(2):217-20. doi: 10.1093/bja/82.2.217.

  PMID: 10364997 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gillian Foxall, MBChB, MA

  Royal Surrey County Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Foxall, MBChB, MA

CONTACT

07917865767; gillianfoxall@nhs.net

Michele N Kigozi, BMedSci,BMBS

CONTACT

07977165224; nabakka@btinternet.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 16, 2011
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

GB (1)