Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/08/2015
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

Mr G Geutjens

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Trauma & Orthopaedics Department
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077186661

Study information

Scientific title

Hamstrings Graft Donor Site Infiltration with Bupivacaine for Pain Relief after Arthroscopically Assisted Anterior Cruciate Ligament Reconstruction

Acronym

Study hypothesis

Does long acting local injected anaesthetic around the hamstrings in addition to femoral nerve block provide better post operative pain relief then femoral nerve block alone in patients having ACL reconstruction with the new ligament taken from their hamstrings tendon?

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Anterior cruciate ligament reconstruction

Intervention

On post operative ward rounds it has been noted that patients often complain that they have pain I their hamstrings during the first 24 hours after surgery. After consultation with the anaesthetic department it has been proposed that the femoral nerve block currently administered for pain relief does not alleviate this pain sufficiently and a more localised infiltration to this area may be variable form person to person. To perform a block on each individual nerve would be impractical as their anatomy is variable and blocks to the obturator nerve are challenging procedure. A local infiltration (injection) at the site of pain is quick, easy and safe and should negate the need for this.

Patients agreeing to take part will be randomly assigned to one of two groups, both of which will receive our current standard post-operative pain relief of femoral nerve block and oral pain killers. The first group (case) will also receive local anaesthetic into the hamstrings (0.375% bupivacaine) and the second group (control) will receive saline into the hamstrings.

Intervention type

Drug

Phase

Not Specified

Drug names

Bupivacaine

Primary outcome measures

Post operative pain scores in the region of the hamstrings

Secondary outcome measures

Not provided at time of registration

Overall trial start date

29/08/2006

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients having primary anterior cruciate ligament reconstruction with hamstrings ipsilateral hamstrings tendon graft, under spinal anaesthesia.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

1. Patients unwilling to participate
2. Those undergoing any procedure other than that described as inclusion criteria
3. Patients unable to consent for themselves
4. Patients with a known allergy to bupivacaine
5. Patients with peripheral neuropathy

Recruitment start date

29/08/2006

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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