Pain management after bunion surgery

Phase 1

• Conditions: management of postoperative pain in ambulatory foot surgery that allows the realization of immediate rehabilitation and better functional results and personal satisfaction; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-001305-82-ES
• Lead Sponsor: aura Perelló Moreno

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Older than 18 years-old.
Both genders.
Types of surgery: Forefoot surgery that includes at least the performance of metatarsal or phalangeal osteotomies and capsular, tendinous or ligamentous soft tissue techniques.
Surgeries performed under the Major Ambulatory Surgery regimen that meet the pain monitoring and monitoring criteria described.
Patients who are operated by any of the 3 members of the foot and ankle unit in the two centers Hospital Son Llàtzer and Clinica Rotger.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergies or intolerances to the medication that is used habitually, making it impossible to administer it.
History of alcoholism or drug abuse that may influence the effect of the analgesia used.
History of known psychiatric diseases that may alter the correct collaboration and monitoring by the patient.
Surgeries that require hospital admission.
Obesity with Body Mass Index (BMI) greater than 35.
Appearance of intraoperative or postoperative complications.
Antecedents of diseases that occur with a decrease in pain threshold, hyperalgesia syndromes or regional anesthesia such as fibromyalgia, neurological or metabolic alterations of sensitivity ...
Patients undergoing percutaneous forefoot surgery, where osteotomies are performed without the use of osteosynthesis material.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified