NCT07336901

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

December 26, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 26, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

gastrosoleus interfascial plane block, knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain using visual analogue score VAS score

    • 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 Outcomes (6)

  • Time to first morphine analgesic dose and total rescue doses of morphine.

    time needed for patient to use morphine in hours after end of surgery

  • cumulative doses of morphine

    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.

    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 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.

    Duration of postoperative hospital stay in days

  • +1 more secondary outcomes

Study Arms (2)

ACB/GIP group

EXPERIMENTAL

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

ACB/IPACK group

EXPERIMENTAL

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

Interventions

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.

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 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).

ACB/GIP group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Korean Knee Society. Guidelines for the management of postoperative pain after total knee arthroplasty. Knee Surg Relat Res. 2012 Dec;24(4):201-7. doi: 10.5792/ksrr.2012.24.4.201. Epub 2012 Nov 29.

    PMID: 23269957BACKGROUND
  • Kim DH, Pearson-Chauhan KM, McCarthy RJ, Buvanendran A. Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty. J Arthroplasty. 2018 Nov;33(11):3372-3378. doi: 10.1016/j.arth.2018.07.028. Epub 2018 Aug 4.

    PMID: 30143334BACKGROUND

Study Officials

  • Alyaa A Hassan, lecturer

    Faculty of medicine, Fayoum university

    PRINCIPAL INVESTIGATOR
  • Mohamed A Shawky, Associate professor

    Faculty of medicine, Fayoum university

    STUDY DIRECTOR
  • Omar S Farghaly, Associate professor

    Faculty of medicine, Fayoum university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyaa A Hassan, lecturer

CONTACT

Rana A Atia, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share