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Clinical Trials/NCT01019005
NCT01019005UnknownNot Applicable

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

Nottingham University Hospitals NHS Trust1 site in 1 country75 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
75
Locations
1
Primary Endpoint
Post-operative pain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • •Inability to communicate
  • •History of alcohol or opioid abuse (also chronic opioid user)
  • •Mental or medical conditions which may affect quantifying pain scores (VAS)

Arms & Interventions

Tibial

Experimental

Intervention: Catheter (Device)

Sham

No Intervention

Intervention: Catheter (Device)

Wound

Experimental

Intervention: Catheter (Device)

Outcomes

Primary Outcomes

Post-operative pain

Time Frame: 2,8,12,24,48 hr

Secondary Outcomes

No secondary outcomes reported

Investigators

Study Sites (1)

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