Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery

NCT06102681 | Suspended

• 1 other identifier: AtiyeErbas
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Accelerated Postoperative Recovery (ERAS) is a multidisciplinary approach aimed at facilitating faster and more effective recovery for patients undergoing surgical procedures. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative phases. Its goal is to enable patients to achieve better outcomes by reducing postoperative pain, complications, and hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions designed to reduce the stress of surgery to maintain anabolic homeostasis and promote recovery. This approach involves preparing patients for surgery through assessment and education, optimizing intraoperative management (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (e.g., through early feeding and mobilization). Early mobilization is considered a crucial element of this approach and is strongly recommended as part of ERAS guidelines across various surgical disciplines. Prolonged bed rest following surgical treatment has been associated with adverse outcomes, such as thromboembolism, pneumonia, muscle weakness, and loss of physical conditioning. If a patient does not have physical limitations in the postoperative period, early ambulation benefits in the preservation of respiratory, circulatory, musculoskeletal, and gastrointestinal system functions, as well as in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, reduces hospital costs, and lightens the workload of healthcare professionals.

Conditions

Spine Fusion; Lumbar Disc Herniation; Cervical Disc Disease

Keywords

quality of life; pain; minimal invasive surgery; ambulation; ERAS; recovery

Outcome Measures

Primary Outcomes (1)

• Pain level

  we will use to measure patient pain level Numeric Pain Scale (NPS) several times. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life).

  before operation and after 10 days operation

Secondary Outcomes (2)

• Life Quality

  before operation and after 10 days operation

• recovery process

  before operation and after 10 days operation

Study Arms (2)

control group

NO INTERVENTION

Patients who are in the control group will receive standard clinical care and these patient will be stand up 1. day after operation.

experimental group

EXPERIMENTAL

Patients who are in the experimental group will receive standard clinical care and they will stand up 8. hours after operation.

Other: intervention group

Interventions

intervention group OTHER

we will measure, consider and compare patients pain level, quality of life and recovery process. For these aims we will use numeric pain scale, nottingham health profile and postoperative recovery index.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective minimal invasive spinal surgery patients

You may not qualify if:

• patients who is under 18 and over 65
• patients who have intubation tupe
• patients have mental disorders
• patients who underwent emergency surgery

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Health Science

Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants will assigned to two grup. one grup will be intervention the other will be control.

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 26, 2023
• Study Start: November 27, 2023
• Primary Completion: May 6, 2024
• Study Completion: September 15, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-10

Locations

TU (1)