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The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery (QoR-15)

Primary Purpose

Post Operative Pain, Anesthesia, Local, Fracture of Hip

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacain (preoperative)
Bupivacaine-fentanyl
Bupivacain (Postoperative)
Sponsored by
Basaksehir Cam & Sakura Şehir Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring Fascia Iliaca Compartment Block, FICB, Partial Hip Arthroplasty Surgery, Quality of Recovery-15

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Partial Hip Arthroplasty American Society of Anesthesiologists (ASA) physical status I-III, Patients aged ≥ 65 years Exclusion criteria: Contraindication for central or peripheral blocks, Cognitive Dysfunction, History of chronic opioid use, Previous hip surgery, Serious organ dysfunction, Allergy to any drug used in the study, Body mass index (BMI) ≥30, Infection in the area to be treated, Refusal to participate in the study

Sites / Locations

  • Ergun MendesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group PreS

Group PostS

Arm Description

The block will be applied in the preoperative period

The block will be applied in the postoperative period

Outcomes

Primary Outcome Measures

Change from baseline QoR-15 at 24 hours postoperatively
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.

Secondary Outcome Measures

Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.
Postoperative nausea and vomiting
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Analgesic consumption
The value in mg of the amount of analgesic consumed in the postoperative period

Full Information

First Posted
July 13, 2023
Last Updated
August 3, 2023
Sponsor
Basaksehir Cam & Sakura Şehir Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05965544
Brief Title
The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery
Acronym
QoR-15
Official Title
The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basaksehir Cam & Sakura Şehir Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.
Detailed Description
American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Anesthesia, Local, Fracture of Hip, QoR-15
Keywords
Fascia Iliaca Compartment Block, FICB, Partial Hip Arthroplasty Surgery, Quality of Recovery-15

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).
Masking
Care ProviderOutcomes Assessor
Masking Description
After each patient's eligibility has been assessed, numbered and sealed envelopes will be used to conceal assignment status. The same clinician (E.M.) will perform the patient's pre- and post-operative procedures. A researcher who does not know which method was applied to the patient in the perioperative and postoperative follow-ups will be included as double-blind.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PreS
Arm Type
Active Comparator
Arm Description
The block will be applied in the preoperative period
Arm Title
Group PostS
Arm Type
Active Comparator
Arm Description
The block will be applied in the postoperative period
Intervention Type
Drug
Intervention Name(s)
Bupivacain (preoperative)
Other Intervention Name(s)
Preoperative Fascia Iliaca Compartment Block
Intervention Description
After the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl
Other Intervention Name(s)
Spinal Anesthesia
Intervention Description
The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space
Intervention Type
Drug
Intervention Name(s)
Bupivacain (Postoperative)
Other Intervention Name(s)
Postoperative Fascia Iliaca Compartment Block
Intervention Description
After the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
Primary Outcome Measure Information:
Title
Change from baseline QoR-15 at 24 hours postoperatively
Description
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
Time Frame
Postoperative 24th-hours
Secondary Outcome Measure Information:
Title
Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
Description
Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.
Time Frame
Postoperative 24th-hours
Title
Postoperative nausea and vomiting
Description
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Time Frame
Postoperative 24th hour
Title
Analgesic consumption
Description
The value in mg of the amount of analgesic consumed in the postoperative period
Time Frame
Postoperative 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Partial Hip Arthroplasty American Society of Anesthesiologists (ASA) physical status I-III, Patients aged ≥ 65 years Exclusion criteria: Contraindication for central or peripheral blocks, Cognitive Dysfunction, History of chronic opioid use, Previous hip surgery, Serious organ dysfunction, Allergy to any drug used in the study, Body mass index (BMI) ≥30, Infection in the area to be treated, Refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ergun Mendes
Phone
+905514265012
Email
erg.mendes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ergun Mendes
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ergun Mendes
City
Küçükçekmece
State/Province
İ̇stanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ergun Mendes
Phone
+905514265012
Email
erg.mendes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
36511494
Citation
Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
Results Reference
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The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery

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