Adductor Canal Block and IPACK Block vs Adductor Canal Block and the Gastrosoleus Interfascial Block After Total Knee Arthroplasty

January 7, 2026 updated by: alyaa abdel sattar mohamed hassan, Fayoum University Hospital

Comparison of Adductor Canal Block and IPACK Block Versus Adductor Canal Block and the Gastrosoleus Interfascial Plane Block for Postoperative Analgesia After Total Knee Arthroplasty: a Prospective Double Blinded Study

Evaluate analgesic efficacy of adductor canal block with IPACK versus that of adductor canal block with gastrosoleus interfascial plane block in total knee arthroplasty surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Total knee arthroplasty (TKA) is a surgical procedure commonly known for its association with sever postoperative pain. This pain can affect quality of recovery by restricting patient's ability to mobilize early and participate effectively in rehabilitation, which eventually will prolong hospital stays and increase healthcare costs. Also chronic postsurgical pain may complicate inadequately managed postsurgical pain.

Hence the need for exploring different analgesic modalities has evolved involving different techniques either regional anesthesia or systemic analgesics.

Peripheral nerve blockade was found to achieve adequate postoperative pain relief, and techniques such as sciatic nerve block, femoral nerve block and adductor canal block have been introduced.

Adductor canal block (ACB) has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function.

Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which may compromise satisfactory pain relief.

Infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) by local anesthetics has been achieved by ultrasound and was found to provide significant posterior knee analgesia. Its technique was described by Elliott et al.

Recently the gastrosoleus interfascial plane block (GIP) was introduced in 2023 by Abraham et al which targets the fascial plane between the soleus muscle and the medial belly of the gastrocnemius muscle.

All patients will be preoperatively assessed then connected to basic monitors (ECG, NIBP and SpO2) IV line will be inserted and crystalloid fluid infusion will be started Patients will be premedicated by midazolam (1-2 mg), and they will be pre oxygenated 3-5 minutes before induction of anesthesia. General anesthesia will be given using propofol 2-3mg/kg intravenous (IV), fentanyl 1-2µg/kg IV and atracurium 0.5 mg/kg IV as a muscle relaxant to facilitate intubation. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Patients will be mechanically ventilated with 50% O2 and 50% air keeping end-tidal CO2 between 30 - 35 mmHg. Fentanyl bolus doses of 0.5-1 mcg/kg will be given according to the changes of hemodynamic variables (more than 20% base line).

Adductor canal block will be given to both groups. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.

The patients in group A will receive gastrosoleus interfascial plane block. The patients in Group B will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion At PACU, all patients will receive paracetamol 1gm to be repeated every 8 hours.

Patients' pain will be assessed using VAS score (12) in the PACU and every 4 hours thereafter for two days. Patient with VAS score ≥4 will recieve a rescue dose of morphine 3-5 mg.

Vital signs including heart rate, systolic and diastolic BP, and oxygen saturation will be recorded intra operatively every 15 min and postoperatively every 4 hours while assessing pain intensity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of ASA class I to III of both sexes
  • undergoing unilateral total knee arthroplasty
  • 40-80 years old

Exclusion Criteria:

  • Patient refusal
  • History of coagulopathies
  • Severe renal insufficiency
  • Preexisting lower limb neurological abnormality
  • Known allergic history to any of the drugs used in this study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACB/GIP group

Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.

The gastrosoleus interfascial plane block will be given along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia.
Procedure: Adductor Canal Block (ACB) + gastrosoleus interfascial plane block

Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.

The patients will receive gastrosoleus interfascial plane block. Using a linear probe the transducer will be placed along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia (loss of resistance).
Experimental: ACB/IPACK group

Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.

The patients will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected.
Procedure: Adductor Canal Block (ACB) + iPACK Block

Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.

The patients will recieve IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative pain using visual analogue score VAS score
Time Frame: change in VAS score 30 min after arrival to PACU change in VAS score 4 hours after arrival to PACU change in VAS score 8 hours after arrival to PACU change in VAS score 12 hours after arrival to PACU change in VAS score 24 hours after arrival to PACU
• Postoperative pain using vas score where 0 is worst pain, 10 is no pain
change in VAS score 30 min after arrival to PACU change in VAS score 4 hours after arrival to PACU change in VAS score 8 hours after arrival to PACU change in VAS score 12 hours after arrival to PACU change in VAS score 24 hours after arrival to PACU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first morphine analgesic dose and total rescue doses of morphine.
Time Frame: time needed for patient to use morphine in hours after end of surgery
Time to first morphine analgesic dose in hours.
time needed for patient to use morphine in hours after end of surgery
cumulative doses of morphine
Time Frame: cumulative doses of morphine in mg in the first 24 hours after operation
cumulative doses of morphine in mg
cumulative doses of morphine in mg in the first 24 hours after operation
Range of motion by assessing degree of knee extension 24 hours after surgery.
Time Frame: Assessing degree of knee extension 24 hours after surgery.
Range of motion by assessing degree of knee extension 24 hours after surgery.
Assessing degree of knee extension 24 hours after surgery.
Time of first postoperative ambulation and how many feets the patient will be able to walk.
Time Frame: Time of first postoperative ambulation and how many feets the patient will be able to walk in the 24 hours after operation
Time of first postoperative ambulation and how many feets the patient will be able to walk.
Time of first postoperative ambulation and how many feets the patient will be able to walk in the 24 hours after operation
Duration of postoperative hospital stay.
Time Frame: Duration of postoperative hospital stay in days
Duration of postoperative hospital stay.
Duration of postoperative hospital stay in days
complications of the block
Time Frame: complications of the block (vascular injury, nerve injury, allergic reaction) in the 24 hours after surgery
vascular injury, nerve injury, allergic reaction
complications of the block (vascular injury, nerve injury, allergic reaction) in the 24 hours after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fayoum University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyaa A Hassan, lecturer, Faculty of medicine, Fayoum university
  • Study Director: Mohamed A Shawky, Associate professor, Faculty of medicine, Fayoum university
  • Principal Investigator: Omar S Farghaly, Associate professor, Faculty of medicine, Fayoum 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

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R761

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

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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