Medial Forefoot Block for Analgesia After Foot Surgery

Hallux Valgus Clinical Trial

Official title:

A Randomised, Blinded Comparison of a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445249
• Other study ID #: 07/H1304/118
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.

Description:

More extensive description not desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Fit adults requiring forefoot surgery with bone cutting

Exclusion Criteria:

• Morbid obesity (BMI > 40)

• Known contraindications to regional anaesthesia

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Procedure:
• Landmark guided ankle block.
25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
• PNS guided block.
This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital. Castle Road, Cottingham,	Hull	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of local anaesthetic block.	The number of patients in each study arm with altered sensation to cold and pin prick, together with no requirement for opiate analgesia, following surgery was recorded.	Over ninety minutes from the start of the study.
Secondary	Intravenous opiate usage following surgery	The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.	24 hours following surgery