Clinical Trials Logo
  1. Home
  2. Orthopedic Surgery
  3. NCT01019005
  4. Details
NCT01019005 Clinical Trial

Pain Relief After Forefoot Surgery

Orthopedic Surgery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01019005
Other study ID # QMC-1975-HJ
Secondary ID QMC-1975-NB
Status Not yet recruiting
Phase N/A
First received November 24, 2009
Last updated November 24, 2009
Start date February 2010
Est. completion date April 2011

Study information
Verified date November 2009
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date April 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Catheter
Catheter inserted into either perineural tibial nerve or wound

Locations
Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative pain 2,8,12,24,48 hr No
See also
  Status Clinical Trial Phase
Completed NCT03657368 - Ventilation Strategy During General Anesthesia for Orthopedic Surgery N/A
Withdrawn NCT02771041 - Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty N/A
Completed NCT02278627 - Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement N/A
Recruiting NCT01205295 - Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment N/A
Completed NCT01389011 - Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery N/A
Completed NCT01063543 - Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Completed NCT03532256 - Post-op Crowd Sourcing Health Data Via Text-messaging
Active, not recruiting NCT03366805 - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery N/A
Completed NCT03769077 - Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP N/A
Recruiting NCT05401058 - Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery N/A
Completed NCT00293631 - Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy Phase 2
Completed NCT05110690 - Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study N/A
Completed NCT05120739 - Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery N/A
Completed NCT00724035 - Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery Phase 4
Completed NCT00702416 - Ultrasound Guidance for Interscalene Brachial Plexus Block Phase 4
Completed NCT00192894 - New Methods to Detect a Decrease in Heart Function Phase 4
Completed NCT05424211 - The Effect of Music Therapy on Pain Level and Analgesic Consumption N/A
Withdrawn NCT00269971 - A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery. Phase 3