NCT03396991

Brief Summary

Background: Recent studies showed the efficiency of several techniques of anesthesia in foot surgery. The new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. The aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

4 days

First QC Date

December 29, 2017

Last Update Submit

September 28, 2021

Conditions

Pain, Postoperative

Keywords

Analgesia techniquePain control

Outcome Measures

Primary Outcomes (1)

  • Pain control measured by a visual analogue scale of Scott-Huskisson (VAS score)

    Pain control measured by a visual analogue scale of Scott-Huskisson (VAS, 0 lack of pain, 10 the worst pain).

    One month

Study Arms (2)

Study Group

In the study Group the investigators enrolled 26 patients scheduled for hallux valgus surgery and treated with a new analgesici approach. After sub-gluteal sciatic nerve block with short acting local anesthetic (mepivacaine 2%, 15 ml), each patient received an ultrasound-guided Posterior Tibial Nerve Block (PTNB) with levobupivacaine 0,5% (7-8 ml). The investigators measured: the intensity of pain at the baseline (before the surgery) and at 3, 6, 12 and 24 hours (h) using a Visual Analogue Scale (VAS); the consumption of oxycodone in the first 24 hours after surgical treatment and the motor recovery using modified Bromage score.

Control group

The investigators compared the study group with a control group of 26 patients previously scheduled for the same surgery and treated with another post-operative analgesia technique more frequently used in our hospital: local infiltration (Local Infiltration Anesthesia, LIA) with levobupivacaine 0, 5% (15 ml) performed by the surgeon directly on the operative site.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

twenty-six consecutive ASA physical status I or II ambulatory patients (study group, SG) scheduled for elective hallux valgus surgery were enrolled. All patients had unilateral procedures

You may qualify if:

  • hallux valgus deformity
  • pain
  • walking difficulty with shoes

You may not qualify if:

  • peripheral circulatory disorders
  • foot skin lesion
  • local anesthetic allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

Location

Related Publications (3)

  • Singelyn FJ. Single-injection applications for foot and ankle surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):247-54. doi: 10.1053/bean.2002.0236.

    PMID: 12491555BACKGROUND

  • Turan I, Assareh H, Rolf C, Jakobsson J. Multi-modal-analgesia for pain management after Hallux Valgus surgery: a prospective randomised study on the effect of ankle block. J Orthop Surg Res. 2007 Dec 18;2:26. doi: 10.1186/1749-799X-2-26.

    PMID: 18088436BACKGROUND

  • Samuel R, Sloan A, Patel K, Aglan M, Zubairy A. The efficacy of combined popliteal and ankle blocks in forefoot surgery. J Bone Joint Surg Am. 2008 Jul;90(7):1443-6. doi: 10.2106/JBJS.G.01133.

    PMID: 18594091BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Giuliano Ferrone

    Fondazione policlinico Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 11, 2018

Study Start

July 1, 2017

Primary Completion

July 5, 2017

Study Completion

October 1, 2017

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)