management of postoperative pain in ambulatory foot surgery that allows the realization of immediate rehabilitation and better functional results and personal satisfaction
Conditions
Interventions
Trade Name: levobupivacaine
Product Name: levobupivacaine
Product Code: 63.171
Pharmaceutical Form: Solution for injection
INN or Propos
Sponsors
Laura Perelló Moreno
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To control pain after outpatient forefoot surgery; Secondary Objective: To improve the performance of immediate self-rehabilitation decrease the need to take rescue analgesia improve the degree of personal satisfaction and the final functional result of the patient demonstrate that there is no greater risk of complications compared to conventional oral analgesia ; Primary end point(s): Being a prospective study, the study will last the time necessary to recruit the required number of individuals. Subsequently these will be followed for a period of 3 months. Additionally, the analysis and the writing of the results will be carried out to write the article. It is expected to last approximately two years. ; Timepoint(s) of evaluation of this end point: Additionally, after the recruitment, the analysis and the writing of the results will be carried out to write the article. It is expected to last approximately two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Subsequently, the analysis of the results will be carried out by a statistical expert and finally, the results will be drafted for presentation at national and / or international congresses and their possible publication in scientific journals.;Timepoint(s) of evaluation of this end point: This will take between 6 months and a year approximately. | — |
Countries
Spain
Contacts
Public ContactTraumatología
Hospital Son Llàtzer
Outcome results
None listed