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

NCT06552897 | Completed

• 1 other identifier: HUACHT-2024-KA01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Management; Total Knee Arthroplasty; Regional Anesthesia; Nerve Blocks

Keywords

Total knee arthroplasty; Adductor canal block,; Selective tibial nerve block; Postoperative analgesia,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Analgesic Consumption

  Within the first 24 hours post-surgery.

• Time to First Additional Analgesic Request

  Within the first 24 hours post-surgery

• Incidence of Side Effects

  Within the first 24 hours post-surgery.

• Patient Satisfaction

  Assessed 24 hours post-surgery.

Study Arms (2)

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

OTHER

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)

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

OTHER

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)

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Health Sciences University Ankara City Hospital

Etimesgut, Ankara, 06790, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28288050 RESULT

• 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.

  PMID: 25386752 RESULT

• 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.

  PMID: 35773028 RESULT

Study Officials

• Semih Başkan

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr. Semih Başkan, Department of Anesthesiology and Reanimation

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 14, 2024
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)