A Comparative Study of Combined Adductor Canal and Interspace Between Popliteal Artery and Knee Capsule Versus Combined Adductor Canal and Genicular Nerve in Total Knee Arthroplasty

March 6, 2025 updated by: Ain Shams University

A Comparative Study of Combined Ultrasound-Guided Adductor Canal Block and Interspace Between the Popliteal Artery and Capsule of the Knee (IPACK) Versus Combined Adductor Canal Block and Genicular Nerve Block Following Total Knee Arthroplasty

The aim of this study is to investigate the effectiveness of combined adductor canal block (ACB) with interspace between popliteal artery and the knee capsule (IPACK) versus combined ACB with genicular nerve block (GNB) for providing analgesia in knee arthroplasty. The investigators hypothesize that the analgesic efficacy of ACB combined with GNB will be non-inferior to that of ACB combined with IPACK. Additionally, the investigators aim to assess whether the combination of ACB and GNB results in a significantly lower occurrence of sensory or motor block affecting the tibial and common peroneal nerves compared to ACB and IPACK

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at lumbar (L2-L3) or (L3-L4) space with 25 ug of fentanyl as adjuvant while patient is in setting position.

In both groups, the adductor canal block (ACB) will be performed with the patient in a supine position, the operative limb externally rotated, and the knee slightly flexed. A high-frequency ultrasound probe (10-15 MHz) will be positioned at the mid-thigh, at the midpoint of the line connecting the patella to the anterior superior iliac spine.

During the procedure, the following structures will be identified: the femoral artery, femoral vein, sartorius muscle, vastus medialis, and adductor longus. The hyperechoic appearance of the saphenous nerve will be visualized lateral to the femoral artery. Using an in-plane technique, 15 mL of 0.25% bupivacaine will be injected to achieve effective analgesia.

For (Group A) To perform the interspace between popliteal artery and knee capsule (IPACK) block, a curvilinear ultrasound probe (2-5 MHz) will first be positioned on the lower third of the medial thigh to identify the femoral vessels. The transducer will then be moved caudally into the popliteal fossa, allowing visualization of the femoral artery as it transitions into the popliteal artery. With the knee flexed at 90°, the needle will be advanced using an in-plane ultrasound-guided technique. The needle trajectory will be from medial to lateral, targeting the space between the popliteal vessels and the posterior capsule of the knee joint. Once the needle tip is positioned approximately 2 cm beyond the lateral border of the popliteal artery, an injection of 15 mL of 0.25% bupivacaine will be administered into this interspace.

For (Group B), The genicular nerve block (GNB) will target three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN). Each nerve will receive an injection of 5 mL of 0.25% bupivacaine.

For SMGN block the high frequency ultrasound probe will be placed laterally over the medial supracondylar area of the femur to identify the SMGN near the superior medial genicular artery, followed by injection adjacent to the artery. For the IMGN, the probe will be positioned over the medial condyle of the tibia to locate the inferior medial genicular artery near the neck of the tibia, again injecting adjacent to the artery. Finally, the SLGN will be targeted by placing the probe over the lateral condyle of the femur to find the superior lateral genicular artery, with the local anesthetic injected nearby.

The investigators will omit the inferolateral genicular nerve (ILGN) block to prevent any unwanted motor weakness or the potential for foot drop that may occur from inadvertently blocking branches of the common peroneal nerve. This decision aligns with the goal of optimizing analgesia while minimizing the risk of motor deficits, ensuring a safer and more effective postoperative recovery for patients undergoing knee arthroplasty.

In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients American Society of anesthesiologists' physical status (ASA) I to III.
  2. Aged 18 to 70 years.
  3. Both sexes.
  4. Patients scheduled for total knee arthroplasty.

Exclusion Criteria:

  1. Patient refusal
  2. ASA physical status IV or more.
  3. Patients with known allergy to any of the study drugs.
  4. Infection at the site of injection.
  5. Patients with neuromuscular disease.
  6. Presence of any coagulopathy.
  7. Patients with history of any psychiatric or cognitive disorder.
  8. patient with previous knee surgery.
  9. BMI more than 40 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients receiving combined ACB and IPACK blocks
ultrasound guided block of saphenous nerve in adductor canal and block of articular branches of knee between the popliteal artery and the knee capsule (IPACK)
Drug: Nerve Block with bupivacaine 0.25%
ultrasound guided combined adductor canal block and genicular nerve block using bupivacaine 0.25%
Active Comparator: Patients receiving combined ACB and GNB
ultrasound guided block of saphenous nerve in adductor canal and block of the three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN)
Drug: nerve block with bupivacaine 0.25%
ultrasound guided adductor canal block and interspace between the popliteal artery and the knee capsule using bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively
Time Frame: 48 hours
(VAS; 0 = no pain and 10 = worst pain imaginable)
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first reported pain and first analgesic request during post-anesthesia care unit stay
Time Frame: 48 hours
reported time in minutes
48 hours
Analgesic consumption during the first 48 h post-surgery
Time Frame: 48 hours
Converted to IV pethidine equivalents. The analgesic dose of pethidine will be 0.5 mg/kg/dose to be repeated on demand
48 hours
Quadriceps muscle strength
Time Frame: 24 hours
will be measured using the Straight Leg Raise (SLR) test, which will be conducted preoperatively and again 24 hours postoperatively. The SLR will be scored on a scale from 0 to 5, where 0 indicates no voluntary contraction, 1 signifies muscle flicker without limb movement, 2 represents active movement with gravity eliminated, 3 indicates movement against gravity but without resistance, 4 denotes movement against some resistance, and 5 reflects normal motor strength against resistance.
24 hours
The sensorimotor functions of the tibial nerve and common peroneal nerve (CPN) will be evaluated using a 3-point scale
Time Frame: 8 hours postoperative
For sensory function, the scale will be as follows: 0 indicates normal sensation, 1 signifies lack of cold perception but intact touch sensation, and 2 denotes absence of touch sensation. For motor function, the scale will be: 0 for normal motor function, 1 for deficient motor function, and 2 for no motor function.
8 hours postoperative
Ambulation and mobilization ability
Time Frame: 48 hours
Assessed using the Timed Up and Go (TUG) test
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R313/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

from 20/2/2025 to 20/9/2025

IPD Sharing Access Criteria

All researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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