Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr S Patil

ORCID ID

Contact details

Ward 34
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom
+44
sunitpatil@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227165434

Study information

Scientific title

Acronym

Study hypothesis

Does pre-operative administration of ankle block (pre-emptive analgesia) provide better post-operative pain control as compared to post-operative ankle block in patients undergoing bony forefoot surgery under a general anaesthetic?

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

Treatment

Patient information sheet

Condition

Surgery: Forefoot

Intervention

Patients meeting the inclusion criteria would be randomised to one of the two groups using a sealed envelope technique.

One group of patients would receive an ankle block using 20ml of 0.25% bupivacaine after they are anaesthetised using a general anaesthetic, 10 minutes before the skin incision. The second group of patients would be administered an ankle block using the same method at the time of wound closure.The patient would be blinded to the type of ankle block.

All the patients would be asked to score their post-operative pain at 4, 8 and 24 hours. The pain would be assessed using linear visual analogue scale. The person assessing the post-operative pain would also be blinded to the type of analgesia. Additional analgesia would be administered on patient's request. This would include 60mg of codeine and 1gm paracetamol. The patients would be asked to note the pain score whenever an analgesic is administered. The time of onset of pain and the frequency of analgesics required would be noted.

Added 27 August 2008: trial stopped due to poor recruitment.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Time of onset of post-operative pain
2. Pain scores at 4, 8 and 24 hours in both groups
3. Requirement of post-operative analgesia

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

30/11/2005

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

1. Patients undergoing bony forefoot surgery under a general anaesthetic
2. ASA grade 1-2

The sample size has been calculated by Dr Arts

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40 patients in each group: 80

Participant exclusion criteria

1. Patients with chronic pain problems
2. Patients with peripheral neuropathy
3. Patients needing regular analgesics for other painful conditions
4. Children of the age of 16 or below

Recruitment start date

01/05/2005

Recruitment end date

30/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward 34
Cleveland
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

South Tees Hospitals 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