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NCT01019005 Clinical Trial

Pain Relief After Forefoot Surgery

Orthopedic Surgery Clinical Trial

Official title:
Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01019005
Other study ID # QMC-1975-HJ
Secondary ID QMC-1975-NB
Status Not yet recruiting
Phase N/A
First received November 24, 2009
Last updated November 24, 2009
Start date February 2010
Est. completion date April 2011

Study information
Verified date November 2009
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date April 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Catheter
Catheter inserted into either perineural tibial nerve or wound

Locations
Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative pain 2,8,12,24,48 hr No
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