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

A Randomized Controlled Trial Investigating the Efficacy of Combined Adductor Canal and Tibial Nerve Blocks for Enhanced Postoperative Pain Management in Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Postoperative Pain Management; Regional Anesthesia; Nerve Blocks
• Intervention / Treatment: Procedure: Intervention 1: Adductor Canal Block (ACB); Procedure: Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Etimesgut, Ankara, Turkey, 06790
      • Health Sciences University Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Levels	The intensity of postoperative pain will be evaluated using the Visual Analog Scale (VAS), a widely used pain assessment tool.Measurement Details: The VAS is a 10-point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable." Higher scores indicate greater pain intensity.	Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Analgesic Consumption	Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.	Within the first 24 hours post-surgery.
Time to First Additional Analgesic Request	Description: The time elapsed from the end of surgery to the first request for additional analgesics will be recorded. Measurement Details: The time (in minutes) from the completion of surgery until the first patient-initiated request for additional analgesia will be measured. A longer duration indicates better initial pain control.	Within the first 24 hours post-surgery
Incidence of Side Effects	Description: The incidence of side effects such as nausea, vomiting, and hypotension will be documented. Measurement Details: The occurrence of these side effects will be recorded as a binary outcome (yes/no). Additionally, the severity of side effects will be assessed using standard clinical grading scales.	Within the first 24 hours post-surgery.
Patient Satisfaction	Patient satisfaction regarding pain management and overall experience will be measured. Measurement Details: Satisfaction will be assessed using a 5-point Likert scale, where 1 represents "very dissatisfied" and 5 represents "very satisfied." Higher scores indicate greater satisfaction.	Assessed 24 hours post-surgery.

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Semih Başkan, Ankara Bilkent City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 10, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Selective tibial nerve block; Adductor canal block,; Postoperative analgesia,
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: HUACHT-2024-KA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No