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

NCT ID: NCT06102681

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-09-15

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.

Detailed Description

Postoperative Accelerated Recovery (ERAS) is a multidisciplinary approach aimed at facilitating the faster and more effective recovery of patients undergoing surgical operations. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative periods. Its objective is to ensure better outcomes for patients by reducing postoperative pain, complications, and the duration of hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions aimed at reducing the stress of surgery to maintain anabolic homeostasis and promote recovery.

This includes preparing the patient for surgery through assessment and education, ensuring the best possible management during surgery (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (for example, through early feeding and mobilization). Early mobilization is considered one of the most crucial elements of this approach and is strongly recommended as part of ERAS guidelines in many surgical disciplines.

Prolonged post-surgical bed rest has been associated with adverse outcomes such as thromboembolism, pneumonia, reduced muscle strength, and physical conditioning loss. If a patient does not have physical limitations in the postoperative period, early mobilization is beneficial in preserving respiratory, circulatory, musculoskeletal, and gastrointestinal system functions and in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, and reduces hospital costs and the workload of healthcare professionals.

Despite the well-recognized importance of early mobilization in surgical procedures, it has been reported that compliance with mobilization goals is low, and those unable to achieve early postoperative mobilization are at a higher risk of complications. Reviewing the literature, it is observed that patients undergoing spinal surgery tend to avoid movement during the postoperative period due to experiencing intense pain before the surgery.

In this context, the aim of this study is to examine the impact of postoperative mobilization timing on patients' recovery status, pain levels, quality of life, and the development of complications following spinal surgery. The results obtained from the study are intended to be reported, thus contributing to the literature in this field and serving as a resource for future studies in this area.

Conditions

Spine Fusion; Lumbar Disc Herniation; Cervical Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

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

Group Type: EXPERIMENTAL

intervention group

Intervention Type: 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.

Interventions

intervention group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Elective minimal invasive spinal surgery patients

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duzce University Faculty of Health Science

Düzce, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AtiyeErbas

Identifier Type: -

Identifier Source: org_study_id