FNB in ACL Recon Under SA

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06048874
• Other study ID #: 2023-07-022-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: September 18, 2028

Study information

• Verified date: September 2023
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 18, 2028
• Est. primary completion date: September 18, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Femoral Nerve Block
• Rupture

Intervention

Procedure:
• Sono-guided injection
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.

Drug:
• Ropivacaine injection
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
• Saline injection
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24hours
Secondary	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.	1, 3, 6, 12, 18, 48 hours