Pain Relief After Forefoot Surgery

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019005

Enrollment

Registered

2009-11-25

Start date

2010-02-28

Completion date

2011-04-30

Last updated

2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Surgery

Keywords

post-operative analgesia, opioid, catheter, tibial nerve block

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.

Interventions

DEVICECatheter

Catheter inserted into either perineural tibial nerve or wound

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

* 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)

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026