Efficacy of Combined Adductor and Tibial Nerve Blocks for Pain Management in Knee Arthroplasty

NCT ID: NCT06552897

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-31

Brief Summary

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This study aims to explore methods for enhancing pain relief following knee replacement surgery, a prevalent procedure for individuals with severe knee arthritis. Effective postoperative pain management is essential for ensuring a swift and comfortable recovery. Traditional pain management methods often involve medications that may have side effects; therefore, this study examines alternative approaches utilizing nerve blocks.

Two pain management methods are compared in this study:

Adductor Canal Block (ACB) Alone: A technique that numbs the anterior and medial regions of the knee.

Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB): An innovative approach that includes an additional block to numb the posterior aspect of the knee.

The objective is to determine whether the combined approach offers superior pain relief, reduces the reliance on pain medications, and enhances overall postoperative recovery. Participants are randomly assigned to one of the two groups and receive the nerve blocks during their surgery.

This study aspires to contribute to the development of improved pain management strategies, facilitating quicker and more comfortable recovery for patients undergoing knee replacement surgery.

Detailed Description

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Total knee arthroplasty (TKA), or knee replacement surgery, is a highly effective treatment for severe knee arthritis, providing significant pain relief and improved joint function. However, managing postoperative pain remains a significant challenge. Effective pain control is essential for facilitating early mobilization, reducing complications, and enhancing overall recovery.

Traditional pain management often relies heavily on opioids, which can cause side effects such as nausea, dizziness, and dependency. To address these concerns, regional anesthesia techniques, including nerve blocks, are increasingly utilized to provide targeted pain relief while minimizing opioid use.

This study evaluates the effectiveness of two nerve block techniques in managing postoperative pain following TKA:

Adductor Canal Block (ACB): This technique targets nerves in the adductor canal, primarily affecting the saphenous nerve, which provides sensation to the anterior and medial regions of the knee. ACB is recognized for preserving muscle strength, thereby facilitating early mobility.

Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB): This approach incorporates a tibial nerve block to address the posterior aspect of the knee, aiming to provide comprehensive pain relief to both the anterior and posterior regions of the knee.

The study is a prospective, randomized controlled trial involving 76 patients undergoing TKA at Health Sciences University Ankara City Hospital. Participants are randomly assigned to receive either the ACB alone or the combined ACB + STNB.

Objectives:

To assess the effectiveness of the combined ACB + STNB in reducing postoperative pain compared to ACB alone.

To evaluate the impact on opioid consumption and overall patient satisfaction. To monitor potential side effects and the time to first additional analgesic requirement.

Methods:

Pain is measured using the Visual Analog Scale (VAS) at multiple time points after surgery.

The study also records total analgesic consumption via patient-controlled analgesia (PCA).

Secondary outcomes include side effects and patient satisfaction scores. The findings of this study could influence future pain management strategies for knee replacement surgeries, potentially offering patients a safer and more effective method for managing postoperative pain with fewer side effects.

Conditions

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Postoperative Pain Management Total Knee Arthroplasty Regional Anesthesia Nerve Blocks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a Parallel Assignment design in which participants undergoing total knee arthroplasty (TKA) are randomly assigned to one of two intervention groups.

Group A: Receives an Adductor Canal Block (ACB) alone, which targets the nerves supplying the front and inner parts of the knee.

Group AT: Receives a combination of Adductor Canal Block (ACB) and Selective Tibial Nerve Block (STNB), providing additional analgesia to the back of the knee.

Both groups are assessed for postoperative pain relief, opioid consumption, side effects, and overall patient satisfaction. The parallel assignment allows for a direct comparison of the effectiveness and safety of these two pain management strategies.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind (Participant, Investigator)

Study Groups

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Arm 1: Adductor Canal Block (ACB) Group, Arm 2: Combined Adductor Canal Block and Selective Tibial N

Arm 1: Adductor Canal Block (ACB) Group Arm Type: Active Comparator Description: This group receives the standard intervention of an Adductor Canal Block (ACB), which serves as the control or comparator arm in the study.

Group Type OTHER

Intervention 1: Adductor Canal Block (ACB)

Intervention Type PROCEDURE

For the Interventions section, you should describe the specific procedures or treatments administered in each arm of your study. Here's how you might present the interventions:

Intervention 1: Adductor Canal Block (ACB) Name: Adductor Canal Block (ACB) Type: Procedure

Description:

Participants receive an ultrasound-guided adductor canal block. Dose and Administration: 20 ml of 0.25% bupivacaine is injected to target the saphenous nerve within the adductor canal.

Objective: To provide analgesia to the anterior and medial aspects of the knee, preserving motor function to facilitate early mobilization.

Arm 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) Group

Arm 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) Group Arm Type: Experimental Description: This group receives the experimental intervention combining Adductor Canal Block (ACB) with Selective Tibial Nerve Block (STNB) to evaluate its efficacy in enhancing postoperative analgesia.

Group Type OTHER

Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)

Intervention Type PROCEDURE

Name: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) Type: Procedure

Description:

Participants receive an ultrasound-guided adductor canal block followed by a selective tibial nerve block.

Dose and Administration:

Adductor Canal Block (ACB): 20 ml of 0.25% bupivacaine. Selective Tibial Nerve Block (STNB): 20 ml of 0.25% bupivacaine. Objective: To provide comprehensive analgesia to both the anterior and posterior aspects of the knee, aiming to enhance pain relief and reduce opioid consumption.

Interventions

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Intervention 1: Adductor Canal Block (ACB)

For the Interventions section, you should describe the specific procedures or treatments administered in each arm of your study. Here's how you might present the interventions:

Intervention 1: Adductor Canal Block (ACB) Name: Adductor Canal Block (ACB) Type: Procedure

Description:

Participants receive an ultrasound-guided adductor canal block. Dose and Administration: 20 ml of 0.25% bupivacaine is injected to target the saphenous nerve within the adductor canal.

Objective: To provide analgesia to the anterior and medial aspects of the knee, preserving motor function to facilitate early mobilization.

Intervention Type PROCEDURE

Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)

Name: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) Type: Procedure

Description:

Participants receive an ultrasound-guided adductor canal block followed by a selective tibial nerve block.

Dose and Administration:

Adductor Canal Block (ACB): 20 ml of 0.25% bupivacaine. Selective Tibial Nerve Block (STNB): 20 ml of 0.25% bupivacaine. Objective: To provide comprehensive analgesia to both the anterior and posterior aspects of the knee, aiming to enhance pain relief and reduce opioid consumption.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age: 18 to 80 years. ASA Classification: Patients classified as ASA I, II, or III. Surgical Procedure: Scheduled for primary unilateral total knee arthroplasty (TKA) under combined spinal-epidural anesthesia.

Informed Consent: Ability to understand and provide written informed consent for participation in the study.

Exclusion Criteria

ASA Classification: Patients classified as ASA IV or V. Surgical History: Revision TKA or any previous knee surgeries on the affected joint.

Medical Conditions:

Infection or neuropathy at the injection site. Coagulopathy or use of anticoagulant medications. Severe cardiac, hepatic, respiratory, or renal disease. Diagnosis of diabetic neuropathy. History of cerebrovascular accident with motor or sensory deficits. Neuropsychiatric disorders that affect cognition or communication.

Pain Management:

Inability to understand or use the Visual Analog Scale (VAS) for pain assessment.

Long-term use of analgesic therapy that could interfere with study assessments. Allergies: Known allergy to local anesthetics used in the study. Block Failure: Failed blocks or anesthesia issues prior to surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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semih başkan

Associate Professor Dr. Semih Başkan, Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semih Başkan

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Locations

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Health Sciences University Ankara City Hospital

Etimesgut, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.

Reference Type RESULT
PMID: 28288050 (View on PubMed)

Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

Reference Type RESULT
PMID: 25386752 (View on PubMed)

Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Ferre F, Naudin C, Joshi GP, Delbos A. Combined proximal or distal nerve blocks for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):427-434. doi: 10.1016/j.bja.2022.05.024. Epub 2022 Jun 28.

Reference Type RESULT
PMID: 35773028 (View on PubMed)

Other Identifiers

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HUACHT-2024-KA01

Identifier Type: -

Identifier Source: org_study_id

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