The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety

The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety in Cases of Lumbar Disc Hernioplasty

we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty.

Study Overview

• Status: Not yet recruiting
• Conditions: Recovery of Postoperative
• Intervention / Treatment: Other: preoperative erector spina plane block; Other: intraoperative erector spina plane block

Detailed Description

Postoperative recovery quality can be tested with the Quality of Recovery-40 (QoR-40) questionnaire. Preoperative anxiety can be detected through structured and standardized screening with the State-Trait Anxiety Inventory (STAI) I and II. In our study, 108 patients between the ages of 18-70 who were planned for lumbar disc hernioplasty will be included. Preoperative Quality of Recovery-40 (QoR40), STAI I and II scores (anxiety questionnaire) will be administered to each patient.The patients will be divided into two groups as preoperative ve intraoperative group. Erector spina plane block will be applied to preoperative group patients in the preoperative period. In the intraoperative group, erector spina plane block will be applied after anesthesia induction. The STAI and Quality of Recovery-40 (QoR40) questionnaire will be repeated postoperatively, the Numerical Rating Scale (NRS) and postoperative patient satisfaction will be measured.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fulya eser çelik; Phone Number: 731039 03125526000; Email: lfulyaeser@hotmail.com
• Study Contact Backup: Name: fatma kavak akelma; Phone Number: 731039 03125526000; Email: fatmakavak@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara City Hospital
    • Contact: fulya eser çelik; Phone Number: 731039 03125526000; Email: lfulyaeser@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-70 years old
• American Society of Anesthesiologists score I-II-III
• Patients who can read and write
• Can speak Turkish language clearly

Exclusion Criteria:

• Visual and hearing impaired
• Those with dementia
• Known serious heart, kidney and liver diseases
• Life-threatening hematological diseases
• Central and peripheral neurological diseases
• Psychiatric disorders
• History of allergy to amide type local anesthetics
• Infection in the block area
• Bleeding diathesis
• Morbidly obese (patients with BMI 40 and above)
• A history of narcotic drug use within 24 hours before the operation
• Those with narcotic substance and alcohol addiction related to chronic pain
• Patients who refused to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: preoperative group; Erector spina plane block will be applied to preoperative group patients in the preoperative period.	Other: preoperative erector spina plane block; Erector spina plane block will be applied to preoperative group patients in the preoperative period.
Active Comparator: intraoperative group; In the intraoperative group, erector spina plane block will be applied after anesthesia induction.	Other: intraoperative erector spina plane block; In the intraoperative group, erector spina plane block will be applied after anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of postoperative functional recovery (QoR-40) score	The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spielberg State-Trait Anxiety Inventory (STAI) score	The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.	4 hours
Numerical Rating Scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): June 7, 2022
• Primary Completion (Anticipated): September 7, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: quality of recovery; block timing; erector spina plan block
• Other Study ID Numbers: Anxiety

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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