Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Technique on the Local Anesthetic Dose Required for Interscalene Brachial Plexus Block

NCT00731146

Arthroscopic Shoulder Surgery

UNKNOWN NA

Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia

NCT01703130

Shoulder Pain

UNKNOWN PHASE4

Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery

NCT04224766

Shoulder Surgery Regional Anesthesia Morbidity

COMPLETED NA

Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?

NCT00497354

Pain After Shoulder Surgery

COMPLETED PHASE3

Analgesic Duration of Long Acting Local Anesthetics for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block

NCT02643563

Brachial Plexus Block Anesthetics, Local

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levobupivicaine Chirocaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No