Pain Relief After Forefoot Surgery

• Sponsor: Nottingham University Hospitals NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01019005
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Duration (Months): 13.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery	Device: Catheter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion
• Study Start Date: Feb 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2011
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Post-operative pain [2,8,12,24,48 hr]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom

Sponsors and Collaborators

• Nottingham University Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01019005
• Other Study ID Numbers: QMC-1975-HJ; QMC-1975-NB
• First Posted: Nov 25, 2009
• Last Update Posted: Nov 25, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: post-operative analgesia; opioid; catheter; tibial nerve block

Study Results

No Results Posted as of Nov 25, 2009