Early Standing in Minors Operated on for Idiopathic Scoliosis (LevPOS)

Early Standing in Children and Adolescent Operated on for Idiopathic Scoliosis

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Scoliosis; ERAS
• Intervention / Treatment: Procedure: anticipated bipedal standing position in the immediate post-operative phase

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Dr DELORT; Phone Number: +33 05 34 55 85 33; Email: delort.f@chu-toulouse.fr
• Study Contact Backup: Name: Delphine Dr KERN; Email: kern.d@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • CHU de Toulouse
    • Contact: Audrey BELLOC; Email: belloc.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of the anticipated bipedal standing position within 6 hours postoperative	success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase within 6 hours postoperative. The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, at six hours postoperative, after validation of the prerequisites for the procedure.	Hour 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain measured by visual analog scale at baseline	pain measured by visual analog scale at baseline. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain	day 0
pain measured by visual analog scale at the first day postoperative	pain measured by visual analog scale at the first day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain	day 1
pain measured by visual analog scale at the second day postoperative	pain measured by visual analog scale at the second day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain	day 2
pain measured by visual analog scale at the third day postoperative	pain measured by visual analog scale at the third day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain	day 3
Morphine consumption baseline	consumption in morphine per day	Day 0
Morphine consumption at Day 1	consumption in morphine per day	Day 1
Morphine consumption at Day 2	consumption in morphine per day	Day 2
Morphine consumption at Day 3	consumption in morphine per day	Day 3
Postoperative length of stay	Postoperative length of stay	Day 7
success of the anticipated bipedal standing position in the early post operative phase (within 2 hours postoperative)	success of a Stand up in a bipedal standing position during more than 3 seconds in the immediate post-operative phase (i.e., within 2 hours postoperative). The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, in the early post operative phase in the post-anesthesia care unit (PACU), after validation of the prerequisites for the procedure.	Hour 2
success of the anticipated bipedal standing position in the early post operative phase (within 3 hours postoperative)	success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase (i.e., within 3 hours postoperative). The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, in the early post operative phase in the post-anesthesia care unit (PACU), after validation of the prerequisites for the procedure.	Hour 3

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: François Dr DELORT, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ERAS; idiopathic scoliosis; physiotherapies
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: RC31/21/0611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No