NCT07539467

Brief Summary

The biggest fear for patients undergoing knee replacement surgery is that persistent pain felt at the back of the knee postoperatively. While regional anesthesia is generally successful at numbing the front of the knee, managing pain in the posterior (back) area is not always easy. In this study, we tested a new method designed to alleviate pain in the back of the knee and improve patient comfort.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 10, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

adductor canal blockOpioid consumptionPostoperative analgesiaTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • This method aims to alleviate posterior knee pain and decrease overall VAS scores

    Visual Analog Scale (VAS): A scale where patients rate their pain intensity from 0 (no pain) to 10 (unbearable pain).

    At 3, 8, 12, and 24 hours post-block

Secondary Outcomes (1)

  • To decrease cumulative opioid requirements and facilitate mobilization while preserving muscle strength

    at 3,8,12,24. post-block hours

Study Arms (2)

Standard Adductor Canal Block Group (S-ACB)

ACTIVE COMPARATOR

Participants received a standard ultrasound-guided distal adductor canal block. During the procedure, 20 mL of 0.25% bupivacaine was injected. In this group, no tourniquet application or additional pressure modification was performed prior to the injection. The technique relied on the natural and passive distribution of the local anesthetic within the canal.

Procedure: Standard Adductor Canal Block (S-ACB)

Tourniquet-Assisted Adductor Canal Block Group (T-ACB)

EXPERIMENTAL

Participants received an ultrasound-guided distal adductor canal block. During the procedure, a pneumatic tourniquet placed on the proximal thigh was inflated for 3-5 minutes (at a pressure of approximately 142-202 mmHg), and 20 mL of 0.25% bupivacaine was injected. Following this, the tourniquet was deflated, and a second 20 mL dose of 0.25% bupivacaine was administered. The aim of this modification was to enhance the distribution of the local anesthetic through the adductor hiatus toward the neural networks of the posterior knee (posterior fascial planes)

Procedure: Tourniquet-Assisted Adductor Canal Block (T-ACB) grou

Interventions

Participants received an ultrasound-guided distal adductor canal block. The procedure was performed in two stages: First, a pneumatic tourniquet placed on the proximal thigh was inflated for 3-5 minutes (at a pressure of approximately 142-202 mmHg), during which 20 mL of 0.25% bupivacaine was injected. Subsequently, the tourniquet was deflated, and an additional 20 mL of 0.25% bupivacaine was administered, reaching a total volume of 40 mL. This technique aimed to enhance the distribution of the local anesthetic through the adductor hiatus to the popliteal plexus at the posterior aspect of the knee.

Tourniquet-Assisted Adductor Canal Block Group (T-ACB)

Participants received a standard ultrasound-guided distal adductor canal block. During the procedure, 20 mL of 0.25% bupivacaine was injected in a single dose without any tourniquet modification or additional pressure application. The technique relied on the natural, passive, and anatomical distribution of the local anesthetic within the adductor canal.

Standard Adductor Canal Block Group (S-ACB)

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • To ensure methodological standardization, the following cases were excluded:
  • Patients undergoing revision surgery.
  • Those undergoing unicompartmental (unicondylar) knee replacement, as the severity of surgical trauma differs from total replacement.
  • Bilateral cases, to prevent potential bias in assessing postoperative opioid consumption and pain scores.
  • Additionally, patients were excluded if:
  • The surgical duration exceeded 180 minutes.
  • There was a known history of coagulopathy, peripheral neuropathy, or allergy to local anesthetics.
  • The spinal anesthesia was insufficient, requiring a conversion to general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik Şehir Hastanesi

Ankara, 06690, Turkey (Türkiye)

Location

Related Publications (1)

  • Sonawane K, Dixit H, Mistry T, Gurumoorthi P, Balavenkatasubramanian J. Anatomical and Technical Considerations of the Hi-PAC (Hi-Volume Proximal Adductor Canal) Block: A Novel Motor-Sparing Regional Analgesia Technique for Below-Knee Surgeries. Cureus. 2022 Feb 6;14(2):e21953. doi: 10.7759/cureus.21953. eCollection 2022 Feb.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients' relatives helped them describe their pain
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: "The control group consisted of patients who underwent the routine adductor canal block, whereas the tourniquet group included patients who received the block with the application of a tourniquet."
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant md

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 20, 2026

Study Start

March 1, 2026

Primary Completion

April 15, 2026

Study Completion

April 16, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data Availability Statement: There are no plans to share individual participant data. Research findings will be reported as collective analyses in scientific journals and academic theses.

Locations