NCT07526831

Brief Summary

To evaluate the effectiveness of Adductor Canal Block and combined Adductor Canal plus IPACK block in reducing postoperative pain and analgesic requirements in patients undergoing knee surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
24mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026May 2028

First Submitted

Initial submission to the registry

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2028

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Postoperative analgesia, Ultrasound, IPACK block, Adductor canal block, Total knee arthroplasty

Outcome Measures

Primary Outcomes (2)

  • opioid consumption

    In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 4 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

    24 hours after surgery

  • Verbal analog Pain Scores on rest and movement

    A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

    24 hours after surgery

Secondary Outcomes (1)

  • incidences of adverse effects (like nausea and vomiting)

    24 hours after surgery

Study Arms (2)

Adductor canal block group(ACB)

Patients in the ACB group (Group I) will receive a single-shot adductor canal block under ultrasound guidance bupivacaine administered preoperatively.

Procedure: Adductor Canal Block Group (Group I)

Adductor canal + iPACK block group(ACB+IPACK)

Patients in the ACB + iPACK group (Group II) will receive a single-shot adductor canal block combined with an infiltration between the popliteal artery and the capsule of the knee (iPACK) under ultrasound guidance bupivacaine.

Procedure: Adductor Canal + iPACK Block Group (Group II)"

Interventions

All patients in Group I will receive a preoperative adductor canal block. In all groups, an intravenous patient-controlled analgesia device containing morphine will be administered for postoperative pain management.

Adductor canal block group(ACB)

All patients in Group II will receive a preoperative adductor canal block combined with an iPACK block. Postoperatively, all patients in both groups will be provided with intravenous patient-controlled analgesia containing morphine for pain management.

Adductor canal + iPACK block group(ACB+IPACK)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥18 years, classified as ASA physical status I-III, scheduled to undergo total knee arthroplasty.

You may qualify if:

  • ASA (American Society of Anesthesiologists) I- ASA II-ASA III Patients

You may not qualify if:

  • history of allergy to the study medication
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sibel Pehlivan

Kayseri, Talas, 38090, Turkey (Türkiye)

RECRUITING

Sibel Seckin Pehlivan

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Shoni M, Samineni AV, Salavati S, Mikkilineni N, Wang A, Abdeen A, Freccero D. Combined Single-Shot Infiltration Between the Popliteal Artery and Capsule of the Knee and Adductor Canal Block With Bupivacaine, Dexmedetomidine, and Dexamethasone for Total Knee Arthroplasty: A Propensity-Matched Analysis. Arthroplast Today. 2023 Dec 28;25:101292. doi: 10.1016/j.artd.2023.101292. eCollection 2024 Feb.

  • Mariano ER, Kim TE, Wagner MJ, Funck N, Harrison TK, Walters T, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of proximal and distal ultrasound-guided adductor canal catheter insertion sites for knee arthroplasty. J Ultrasound Med. 2014 Sep;33(9):1653-62. doi: 10.7863/ultra.33.9.1653.

Related Links

Study Officials

  • Sibel Pehlivan

    Erciyes Üniversitesi

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 12 months of study completion
Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Locations