Early Standing in Minors Operated on for Idiopathic Scoliosis

NCT ID: NCT06152601

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-12-31

Brief Summary

The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Investigators are already applying anesthetic, surgical, peri-operative medicine and rehabilitation techniques allowing accelerated and improved rehabilitation for scoliosis operated patients in the establishment. To improve patient care, the Investigators want to develop the ERAS program. The objective of this research will be to validate the feasibility of getting up early on D0 in post-anesthesia care unit (PACU) or ICU in children who have just had surgery for idiopathic scoliosis.

Detailed Description

The study hypothesize that entry into an early mobilizing physiotherapy program, i.e., from the immediate postoperative period, from the PACU or the ICU, could improve the outcome of patients in terms of pain, anxiety, re-empowerment, length of stay and ultimately overall satisfaction.

Following a general anesthesia, the patient is monitored in the PACU the time to recover respiratory, neurological and hemodynamic autonomy. It is also in PACU that the team optimize pain management, through opioid treatments if necessary.

The first physiotherapy sessions including sitting on the edge of the bed and getting up for the first time are technical acts that require good cooperation from the patient and adequate pain relief. Usually, physiotherapy rehabilitation is started on the first postoperative day. However, once the stability of vital functions and the analgesia have been optimized, the early postoperative phase seems to be a privileged moment to begin this rehabilitation program. This early physiotherapy treatment could also have a beneficial psychological effect on the rest of the treatment.

Although most centers tend to generalize ERAS programs and early rehabilitation techniques, to date there is no publication on the feasibility of early rehabilitation from the immediate postoperative period, nor on the expected benefit of such a program. The fact of starting the rehabilitation immediately postoperatively or as soon as the PACU could have several advantages. The optimization of pain management performed in the PACU could facilitate the physiotherapy session. In addition, it turns out that the rehabilitation and progressive re-empowerment of the patient have a positive psychological and physical effect on the rest of the treatment. The early re-empowerment of the patient allows him to regain control of his body and his care which has a positive psychological effect on the care. Early mobilization fights muscle contracture with positive effects on pain and patient comfort.

This research propose to validate the feasibility of standing up early on D0 in PACU or ICU in children who have just had surgery for idiopathic scoliosis. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Conditions

Idiopathic Scoliosis; ERAS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group experimental

Patient between 12 and 18 years old with a spinal surgery for idiopathic scoliosis programmed. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Group Type: EXPERIMENTAL

anticipated bipedal standing position in the immediate post-operative phase

Intervention Type: PROCEDURE

Realization of a first stand-up within 6 hours after entry into PACU or extubation for admitted patients intubated, in PACU or on admission to ICU by a state-certified physiotherapist.

Immediately postoperatively, during his stay in a Intensive Care Unit, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Interventions

anticipated bipedal standing position in the immediate post-operative phase

Realization of a first stand-up within 6 hours after entry into PACU or extubation for admitted patients intubated, in PACU or on admission to ICU by a state-certified physiotherapist.

Immediately postoperatively, during his stay in a Intensive Care Unit, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Programming of spinal surgery via the posterior approach for idiopathic scoliosis eligible for an ERAS program
• Person affiliated or beneficiary of a social security scheme
• Free, informed and written consent signed by the legal guardians of the minor patient
• Free and informed consent of the minor patient

Exclusion Criteria

• Scoliosis linked to a neuromuscular pathology
• Physical status score of American Society of Anesthesiologists (ASA) > 2
• Severe or unbalanced associated conditions (cardiac, pulmonary, coagulopathy or anticoagulant treatment with curative intent, long-term corticosteroid therapy)
• Malnutrition
• Major cognitive disorders
• Impossibility for the parent(s) to contact the pediatrician or the hospital service if necessary (minor patients)
• Pregnancy
• Feeding with milk
• Severe disability related to scoliosis with impossibility of ambulation
• Surgical assembly planned unstable or requiring the wearing of a corset
• Refusal of minor patient or of the legal guardians of the minor patient
• Patient under legal protection, guardianship or curatorship

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Dr DELORT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de TOULOUSE

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François Dr DELORT

Role: CONTACT

delort.f@chu-toulouse.fr

05 34 55 85 33 ext. +33

Delphine Dr KERN

Role: CONTACT

kern.d@chu-toulouse.fr

Facility Contacts

Audrey BELLOC

Role: primary

belloc.a@chu-toulouse.fr

Other Identifiers

RC31/21/0611

Identifier Type: -

Identifier Source: org_study_id