Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0355135209
Study information
Scientific title
Acronym
Study hypothesis
1. To ascertain whether the combined mixture of equal volumes of 0.5% Bupivacaine (+ Adrenaline 1:200,000) and 1% Lignocaine leads to a clinically superior block, when compared to 0.375% Ropivacaine.
2. Does the mixture have a similar onset of action (OOA), duration of action (DOA), Surgical and Anaesthetic satisfaction, and patient satisfaction when compared to Ropivacaine?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
The patients will be randomly assigned to one of two groups:
GROUP M will receive the mixture of 0.5% Bupivacaine (+ Adrenaline 1:200,000), 20 ml, with 1% lignocaine 30 ml (400 mg total).
GROUP R will receive 0.375% Ropivacaine, 50 ml (187.5 mg total).
A blind observer then will assess sensory and motor block. The sensory block assessment in keeping with previous research will be performed with a short beveled, 23-gauge needle in the innervation areas of the median n. radial n. ulnar n. and musculocutaneous n. and compared to the opposite side. (0 = no block, 1 = loss of sensation to pinprick, 2 = loss of sensation to touch). The degree of motor block will be tested by thumb abduction (radial n), thumb adduction (ulnar n), thumb opposition (median n.) and flexion of the elbow in supination and pronation of the forearm (musculocutaneous n.). (0 = no block, 1 = partial motor block, 2 = complete motor block). The assessment of the sensory and motor block will be made at 5, 10, 15, 20, 30 and 40 min intervals following the completion of the local anaesthetic (LA) injection. It will also continue at 60 min intervals following the cessation of surgery, until either the block has disappeared or the time is midnight and the patient will need to sleep. The time needed for each patient to be ready for surgery (= a grade 1 block for both sensory and motor testing in all areas) will also be recorded. Surgery will be able to start if either pinprick testing reveals analgesia in all areas, or at 50 min if the region to be operated on is adequately analgesed. If adequate analgesia does not occur by 50 min, the block may be supplemented with a peripheral local infiltration of 1% Lignocaine by the Surgeon. Should the block still not be adequate, then the patients will receive a general anaesthetic and be excluded from the trial. Intra-operatively, if the patient feels any discomfort, further sedation and intravenous (iv) fentanyl will be administered and recorded. Also, any iv analgesia in the 24/24 period following surgery will be recorded. At the end of surgery, it is proposed that the Surgeon and Anaesthetist will independently assess the overall quality of the block on a three point scale for both analgesia and muscle relaxation. (0 = unsatisfactory, 1 = satisfactory, 2 = excellent). In addition, the patients will be asked by an observer (unaware of group assignment) to give a score of the quality of there own analgesia as they perceived it. (0 = poor, 1 = sufficient, 2= excellent).
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Degree and quality of local anaesthetic blocks in two groups of patients.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2004
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. American Society of Anesthesiologists (ASA) I - III
2. Age above 16 years, weight between 60 - 100 kg and height above 150 cm
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Pre-existing neurological, cardiovascular, lymphatic and hepatic conditions
2. Psychiatric disease, alcohol or drug abuse
3. Allergy or other reactions to LA
4. Age <16 or >75, weight <60 kg or >100 kg
5. Pregnancy
6. Procedures where postoperative bandaging would significantly interfere with the researchers neurological assessment
Recruitment start date
01/02/2004
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mid Essex Hospital Services NHS Trust (BH)
Chelmsford
CM1 7ET
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Mid Essex Hospital Services NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary