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Pain Relief After Forefoot Surgery

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NHS Trust

Status

Unknown

Conditions

Orthopedic Surgery

Treatments

Device: Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01019005
QMC-1975-NB (Other Identifier)
QMC-1975-HJ

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups

Tibial
Experimental group
Treatment:
Device: Catheter
Wound
Experimental group
Treatment:
Device: Catheter
Sham
No Intervention group
Treatment:
Device: Catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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