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FNB in ACL Recon Under SA

Primary Purpose

Anterior Cruciate Ligament Rupture, Femoral Nerve Block

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sono-guided injection
Ropivacaine injection
Saline injection
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate. Exclusion Criteria: who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear. who have previously undergone surgical treatment within the knee joint. who have declined to participate in the research. where medical, surgical, or anesthetic complications occurred during surgery. other cases deemed necessary by the researchers.

Sites / Locations

  • Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FNB

no FNB

Arm Description

sono-guided injection with 20ml ropivacaine

sono-guided injection with 20ml 0.9% saline

Outcomes

Primary Outcome Measures

postoperative pain after 24hours
VAS (Visual analog scale) measured 24 hours after operation the unabbreviated scale title: The visual analog scale the minimum and maximum values: 0, 10 higher scores mean a worse outcome.

Secondary Outcome Measures

postoperative pain after 1, 3, 6, 12, 18, 48 hours
VAS (Visual analog scale) measured 1, 3, 6, 12, 18, 48 hours after operation the unabbreviated scale title: The visual analog scale the minimum and maximum values: 0, 10 higher scores mean a worse outcome.

Full Information

First Posted
September 13, 2023
Last Updated
September 20, 2023
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06048874
Brief Title
FNB in ACL Recon Under SA
Official Title
Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
September 18, 2028 (Anticipated)
Study Completion Date
September 18, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

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

5. Study Description

Brief Summary
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.
Detailed Description
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Femoral Nerve Block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FNB
Arm Type
Experimental
Arm Description
sono-guided injection with 20ml ropivacaine
Arm Title
no FNB
Arm Type
Placebo Comparator
Arm Description
sono-guided injection with 20ml 0.9% saline
Intervention Type
Procedure
Intervention Name(s)
Sono-guided injection
Intervention Description
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
Intervention Type
Drug
Intervention Name(s)
Saline injection
Intervention Description
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
Primary Outcome Measure Information:
Title
postoperative pain after 24hours
Description
VAS (Visual analog scale) measured 24 hours after operation the unabbreviated scale title: The visual analog scale the minimum and maximum values: 0, 10 higher scores mean a worse outcome.
Time Frame
24hours
Secondary Outcome Measure Information:
Title
postoperative pain after 1, 3, 6, 12, 18, 48 hours
Description
VAS (Visual analog scale) measured 1, 3, 6, 12, 18, 48 hours after operation the unabbreviated scale title: The visual analog scale the minimum and maximum values: 0, 10 higher scores mean a worse outcome.
Time Frame
1, 3, 6, 12, 18, 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate. Exclusion Criteria: who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear. who have previously undergone surgical treatment within the knee joint. who have declined to participate in the research. where medical, surgical, or anesthetic complications occurred during surgery. other cases deemed necessary by the researchers.
Facility Information:
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
24253
Country
Korea, Republic of

12. IPD Sharing Statement

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FNB in ACL Recon Under SA

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