Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees

ISRCTN ISRCTN68691928
DOI https://doi.org/10.1186/ISRCTN68691928
EudraCT/CTIS number 2007-000619-27
Secondary identifying numbers 56481676
Submission date
29/05/2007
Registration date
16/07/2007
Last edited
13/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
An amputation is the surgical removal of part of the body, such as an arm or leg. In the UK, about 5000 people each year have their leg amputated. Patients usually have a long hospital stay, require long-term rehabilitation and frequently need institutional support on leaving hospital. After surgery, patients may experience severe pain as well as phantom pain and phantom sensations. So-called ‘stump pain’ comes from the wound site itself. Although a good recovery is possible after amputation, pain complicates rehabilitation, making it more difficult to use prosthetic limbs and regain mobility, limiting independence and the ability to work. Chronic pain can also cause depression, sleep deprivation, a reluctance to socialise, and difficulties with everyday activities. Phantom limb pain is particularly difficult to treat, with many sufferers relying on strong painkillers such as morphine. These are not always successful and often cause significant side effects. We are performing a study of a new technique to find out how it affects pain after amputation.

Who can participate?
Patients requiring a below or above knee amputation because of vascular (blood vessel) disease.

What does the study involve?
The new technique involves placing a small tube, called a catheter, directly into the major nerve of the leg (the sciatic nerve) at the time of surgery and infusing a local anaesthetic called levobupivacaine for 4 days. The research team are assessing the effects of this new treatment on pain early after surgery, and the incidence and severity of phantom limb over the following 6 months. The team are also assessing the long-term physical and psychological effects on mood, physical disability and quality of life.

What are the possible benefits and risks of participating?
The researchers believe the new technique that they are investigating has the potential to relieve pain, aid rehabilitation and improve quality of life for people who have had their leg amputated because of vascular disease. This study will reveal whether their technique does give these benefits. If proved effective, it is possible this technique could also be used in people who are undergoing amputations for other reasons, for example severe traumatic injuries or bone cancer. An effective treatment that relieves pain could make a real difference to people who have had their leg amputated. Coping with pain can be exhausting. Freedom from pain could reduce people’s reliance on painkillers and hugely improve their well-being and quality of life. Freedom from pain after surgery could boost patients’ chances of making a good recovery and reduce the time spent in hospital. It could help patients use prosthetic limbs more successfully, improve mobility and aid rehabilitation. These factors contribute to providing patients with greater potential for living independently after surgery and of returning to work. In addition, the increased independence and improved body image that come with successful rehabilitation can significantly boost people’s self-esteem. There are no specific risks to taking part in the study but patients are attached to a small infusion device for 4 days after surgery.

Where is the study run from?
Leicester Royal Infirmary (UK).

When is the study starting and how long is it expected to run for?
From July 2007 to December 2012.

Who is funding the study?
Action Medical Research (UK).

Who is the main contact?
Dr Jonathan Thompson
jt23@le.ac.uk

Contact information

Dr Jonathan Thompson
Scientific

University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Phone +44 (0)116 258 5291
Email jt23@le.ac.uk

Study information

Study designRandomised placebo-controlled double-blind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleProspective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees
Study objectivesThat continuous neural sheath infusion of levobupivacaine after major lower limb amputation will reduce the incidence of late phantom pain/phantom limb sensations and stump pain.

On 16/10/2012 the overall trial end date was changed from 01/01/2010 to 31/12/2012.
Ethics approval(s)Trent Research Ethics Committee, 13/08/2007, ref: 07/H0405/42
Health condition(s) or problem(s) studiedLower limb amputation
InterventionPerineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levobupivacaine
Primary outcome measureCurrent primary outcome measure as of 15/09/2021:
Late stump pain, phantom limb sensations and phantom limb pain up at 6 months after surgery.


Previous primary outcome measure:
Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery.
Secondary outcome measuresCurrent secondary outcome measures as of 15/09/2021:
The following will be measured at 6 weeks, 3 months, and 6 months after surgery:
1. Early postoperative pain and morphine requirements
2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability)


Previous secondary outcome measures:
1. Early postoperative pain and morphine requirements
2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability)

Secondary outcomes will be measured at 6 weeks, 3, 6 and up to 12 months after surgery.
Overall study start date01/07/2007
Completion date03/10/2012

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants132
Total final enrolment90
Key inclusion criteriaPatients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology.
Key exclusion criteriaCurrent exclusion criteria as of 24/08/2021:

1. Patients not considered for surgical intervention
2. Patients who are deemed unfit to undergo surgery under general anaesthesia
3. Patients undergoing surgery under regional anaesthesia
4. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states
5. Patients unwilling to consent
6. Allergy to any study medication

_____

Previous exclusion criteria:

1. Patients not considered for surgical intervention
2. Patients who are deemed unfit to undergo surgery under general anaesthesia
3. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states
4. Patients unwilling to consent
5. Allergy to any study medication
Date of first enrolment01/07/2007
Date of final enrolment03/10/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospitals of Leicester NHS Trust
Leicester
LE1 5WW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

Phone +44 116 258 4199
Email djr8@le.ac.uk
Website http://www.uhl-tr.nhs.uk/
ROR logo "ROR" https://ror.org/02fha3693

Funders

Funder type

Research organisation

Association of Anaesthetists of Great Britain and Ireland (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPresentations at scientific meetings and planned publication in a high impact peer reviewed journal.
Data presented in part at BJA Research Forum, December 2019 and published in abstract form in the British Journal of Anaesthesia April 2020
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results 01/04/2020 24/08/2021 No No
Basic results 24/08/2021 24/08/2021 No No
Results article 01/04/2020 24/08/2021 Yes No
Results article 10/02/2023 13/02/2023 Yes No

Additional files

ISRCTN68691928_BasicResults_24Aug2021.pdf
ISRCTN68691928 PLP BJA res forum abstract BJA April 2020.pdf

Editorial Notes

13/02/2023: Publication reference added.
15/09/2021: The following changes have been made:
1. The primary outcome measure has been updated.
2. The secondary outcome measures have been updated.
3. The EudraCT number has been added.
4. The plain English summary has been updated to reflect the changes above.
24/08/2021: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. Publication references added.
3. The total final enrolment was added.
4. The exclusion criteria were changed.
5. The recruitment end date was changed from 31/12/2012 to 03/10/2013.
6. The publication and dissemination plan was added.
7. The participant level data was changed from "Not provided at time of registration" to "Available on request"
8. The overall end date was changed from 31/12/2012 to 03/10/2012.
9. The target number of participants, was changed from 62 to 132.
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.