Pain Relief After Forefoot Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Device: Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative pain	2,8,12,24,48 hr

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 24, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: opioid; post-operative analgesia; catheter; tibial nerve block
• Other Study ID Numbers: QMC-1975-HJ; QMC-1975-NB (Other Identifier: QMC)