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Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Primary Purpose

Analgesia, Scoliosis Idiopathic, Surgery

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Enhanced recovery pathway

About this trial

This is an interventional treatment trial for Analgesia focused on measuring enhanced recovery pathway, analgesia, tele-monitoring, biopsychosocial evaluation

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

approved written informed consent by parent or legal representative
idiopathic adolescent scoliosis
planned for elective surgery: posterior spinal fusion

Exclusion Criteria:

other types of scoliosis
chronic opioid usage (more than 3 months)
known unstable psychiatric medical condition

Sites / Locations

University hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

Enhanced recovery pathway

Arm Description

Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis

Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol

Outcomes

Primary Outcome Measures

postoperative pain

Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively

Secondary Outcome Measures

evaluation of opioid-related side effect

Evaluation of opioid-related side effect as nausea, vomiting and pruritus

sleep

Subjective sleep score using 11 point numeric rating scale

daily activity

Subjective activity score using 11 point numeric rating scale

mobility

Daily mobility assessment by attending physiotherapist on 4 point scale

Full Information

NCT ID

NCT04038229

First Posted

July 26, 2019

Last Updated

May 12, 2023

Sponsor

University Hospital, Antwerp

1. Study Identification

Unique Protocol Identification Number

NCT04038229

Brief Title

Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Official Title

Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 9, 2019 (Actual)

Primary Completion Date

November 3, 2021 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. The consequences of untreated acute pain are known and can also contribute to chronification in pain.

Detailed Description

Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. The consequences of untreated pain are known and can also contribute to chronification in pain. The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Scoliosis Idiopathic, Surgery, Postoperative Pain

Keywords

enhanced recovery pathway, analgesia, tele-monitoring, biopsychosocial evaluation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis

Arm Title

Enhanced recovery pathway

Arm Type

Experimental

Arm Description

Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol

Intervention Type

Other

Intervention Name(s)

Enhanced recovery pathway

Intervention Description

The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term

Primary Outcome Measure Information:

Title

postoperative pain

Description

Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively

Time Frame

From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively

Secondary Outcome Measure Information:

Title

evaluation of opioid-related side effect

Description

Evaluation of opioid-related side effect as nausea, vomiting and pruritus

Time Frame

From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

Title

sleep

Description

Subjective sleep score using 11 point numeric rating scale

Time Frame

From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

Title

daily activity

Description

Subjective activity score using 11 point numeric rating scale

Time Frame

From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

Title

mobility

Description

Daily mobility assessment by attending physiotherapist on 4 point scale

Time Frame

From day of surgery until hospital discharge (approximately 7 days)

Other Pre-specified Outcome Measures:

Title

State-Trait anxiety Inventory (STAI)

Description

evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform

Time Frame