A comparison of equal volumes of a mixture of 0.5% Bupivacaine (+ adrenaline 1:200,000) with 1% Lignocaine; and 0.375% Ropivacaine for Axillary Brachial Plexus Anaesthesia
| ISRCTN | ISRCTN44108778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44108778 |
| Secondary identifying numbers | N0355135209 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sandip Pal
Scientific
Scientific
Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Degree and quality of local anaesthetic blocks in two groups of patients. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2004 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mid Essex Hospital Services NHS Trust (BH)
Chelmsford
CM1 7ET
United Kingdom
CM1 7ET
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Mid Essex Hospital Services NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
