AzTrials
AzTrials

Postoperative Pain ManagementCATNAPNCT06552897

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

A study testing Intervention 1: Adductor Canal Block (ACB) and Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) in people with Postoperative Pain Management and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intervention 1: Adductor Canal Block (ACB) and Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University Ankara City Hospital

    Etimesgut, Ankara, 06790

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Intervention 1: Adductor Canal Block (ACB), Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)
Keywords
Total knee arthroplasty, Adductor canal block,, Selective tibial nerve block, Postoperative analgesia,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention 1: Adductor Canal Block (ACB)Procedure or surgery

    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 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)Procedure or surgery

    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.

Study groups in NCT06552897
Study groupRoleWhat they receive
Arm 1: Adductor Canal Block (ACB) Group, Arm 2: Combined Adductor Canal Block and Selective Tibial NOtherArm 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.
Receives: Procedure: Intervention 1: Adductor Canal Block (ACB)
Arm 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) GroupOtherArm 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.
Receives: Procedure: Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.

Secondary outcomes (4)
  1. Total Analgesic Consumption

    Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.

    Measured: Within the first 24 hours post-surgery.

  2. 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.

    Measured: Within the first 24 hours post-surgery

  3. 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.

    Measured: Within the first 24 hours post-surgery.

  4. 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.

    Measured: Assessed 24 hours post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start1 May 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552897
Sponsor's protocol ID
HUACHT-2024-KA01
Acronym
CATNAP
Status last verified
Sep 2024
First submitted
5 Aug 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28288050
  • 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.

    PubMed 25386752
  • 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.

    PubMed 35773028

Questions about this trial

What is this clinical trial studying?

A study testing Intervention 1: Adductor Canal Block (ACB) and Intervention 2: Combined Adductor Canal Block and Selective Tibial Nerve Block (ACB + STNB) in people with Postoperative Pain Management and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Levels (time frame: Pain levels will be assessed at 0, 1, 2, 8, 12, and 24 hours following the completion of the surgical procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06552897, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

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