Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

Anterior Cruciate Ligament Injuries Clinical Trial

— DUAL  

Official title:

Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532618
• Other study ID #: NL 81489.100.22
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

Description:

Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.

Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).

Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Undergoing anterior cruciate ligament surgery under general anesthesia

• ASA I-III

Exclusion Criteria:

• Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,

• Neuromuscular disorders

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Adductor canal block
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.

Drug:
• Levobupivacaine
Levobupivacaine
• Placebo
10 ml of sodium chloride 0.9%

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21. — View Citation

Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain level	Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine	Within first 48 hours after surgery
Secondary	Opiate use	postoperative use of opiates (Morphine equivalent dose (mg))	Within first 48 hours after surgery
Secondary	Nausea	Postoperative nausea (yes/no)	Within first 48 hours after surgery
Secondary	Block result	If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score	within first 24 hours after surgery
Secondary	Patient satisfaction	Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied	48 hours after surgery