Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

NCT05532618 | Completed

• 1 other identifier: NL 81489.100.22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anterior Cruciate Ligament Injuries

Keywords

adductor canal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Opiate use

  Within first 48 hours after surgery

• Nausea

  Within first 48 hours after surgery

• Block result

  within first 24 hours after surgery

• Patient satisfaction

  48 hours after surgery

Study Arms (2)

Levobupivacaine

ACTIVE COMPARATOR

Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound

Procedure: Adductor canal block; Drug: Levobupivacaine

Placebo

PLACEBO COMPARATOR

Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound

Procedure: Adductor canal block; Drug: Placebo

Interventions

Adductor canal block PROCEDURE

Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.

Levobupivacaine; Placebo

Levobupivacaine DRUG

Levobupivacaine

Levobupivacaine

Placebo DRUG

10 ml of sodium chloride 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Undergoing anterior cruciate ligament surgery under general anesthesia
• ASA I-III

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 23788068 BACKGROUND

• 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.

  PMID: 31980156 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Leon Timmerman, dr

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medication is prepared by study personell not otherwise involved in the study according to a computer generated randomization plan. This plan will be available for analyses after the study. Primary investigator is able to retreive the allocation prematurely if indicated (emergency).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD, principal investigator

Model Details: Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 8, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of the results, for at least 15 years.
• Access Criteria: Data will be available on request. If a journal allows online sharing of IPD with a publication, this will be considered as well.

Locations

NL (1)