Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
25/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sandip Pal

ORCID ID

Contact details

Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes