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Pain Relief After Forefoot Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019005
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nottingham University Hospitals NHS Trust
  Purpose

The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery

In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.


Condition Intervention
Orthopedic Surgery Device: Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion

Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:
  • Post-operative pain [ Time Frame: 2,8,12,24,48 hr ]

Estimated Enrollment: 75
Study Start Date: February 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibial Device: Catheter
Catheter inserted into either perineural tibial nerve or wound
Experimental: Wound Device: Catheter
Catheter inserted into either perineural tibial nerve or wound
No Intervention: Sham Device: Catheter
Catheter inserted into either perineural tibial nerve or wound

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older (ASA I & II)
  • Able to give written consent
  • Patients having elective forefoot surgery with a planned ankle block.
  • Expected postoperative pain to be at least moderate in severity the day following surgery

Exclusion Criteria:

  • Refusal
  • Inability to communicate
  • History of alcohol or opioid abuse (also chronic opioid user)
  • Mental or medical conditions which may affect quantifying pain scores (VAS)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019005


Locations
United Kingdom
Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
  More Information

Responsible Party: Nottingham University Hospitals NHS Trust, Queens' Medical Centre
ClinicalTrials.gov Identifier: NCT01019005     History of Changes
Other Study ID Numbers: QMC-1975-HJ
QMC-1975-NB ( Other Identifier: QMC )
First Submitted: November 24, 2009
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Nottingham University Hospitals NHS Trust:
post-operative analgesia
opioid
catheter
tibial nerve block