Pain Relief After Forefoot Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Nottingham University Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01019005
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 24, 2009
Last Updated: November 24, 2009
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on August 01, 2014