Pain Relief After Forefoot Surgery

Not Applicable

• Conditions: Orthopedic Surgery
• Interventions: Device: Catheter

• Registration Number: NCT01019005
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Last Update Submitted: 2009-11-24
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25
• Study Start: 2010-02
• Primary Completion: 2011-02
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tibial	Catheter	-
Wound	Catheter	-
Sham	Catheter	-

Primary Outcome Measures

Name	Time	Method
Post-operative pain	2,8,12,24,48 hr

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom