Clinical trial NCT06552897: Efficacy of Combined Adductor and Tibial Nerve Blocks for Pain Management in Knee Arthroplasty
Official title: A Randomized Controlled Trial Investigating the Efficacy of Combined Adductor Canal and Tibial Nerve Blocks for Enhanced Postoperative Pain Management in Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management
Total Knee Arthroplasty
Regional Anesthesia
Nerve Blocks
Keywords: Total knee arthroplasty
Adductor canal block,
Selective tibial nerve block
Postoperative analgesia,
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain Levels
timeFrame: Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.
Secondary outcomes:
measure: Total Analgesic Consumption
timeFrame: Within the first 24 hours post-surgery.
measure: Time to First Additional Analgesic Request
timeFrame: Within the first 24 hours post-surgery
measure: Incidence of Side Effects
timeFrame: Within the first 24 hours post-surgery.
measure: Patient Satisfaction
timeFrame: Assessed 24 hours post-surgery.
Other outcomes:
Locations:
city: Etimesgut
country: Turkey
facility: Health Sciences University Ankara City Hospital
state: Ankara
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Semih Başkan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.