NCT05473559

Brief Summary

Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

July 22, 2022

Last Update Submit

July 22, 2022

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    24 hours

    24 hours post operative

Study Arms (2)

Adductor canal block with Ipack block

ACTIVE COMPARATOR
Procedure: Adductor canal block with Ipack block or selective tibial nerve block

Adductor canal block with selective tibial nerve block

ACTIVE COMPARATOR
Procedure: Adductor canal block with Ipack block or selective tibial nerve block

Interventions

Adductor canal block with Ipack block or selective tibial nerve blockPROCEDURE

Ultrasound guided

Adductor canal block with Ipack blockAdductor canal block with selective tibial nerve block

Eligibility Criteria

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

You may qualify if:

  • Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty • Patients aged 40-80 years with a body mass index of 18-36 kg/ m2 and an American Society of Anesthesiologists functional status of I-III Planned use of regional anesthesia

You may not qualify if:

  • Patients younger than 40 years old and older than 80years.
  • Hepatic or renal insufficiency.
  • Patients undergoing general anesthesia.
  • Allergy or intolerance to one of the study medications.
  • BMI \> 36
  • Diabetes
  • ASA of IV
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Egypt

Location

Study Officials

  • Marwa Abogabal, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Wafaa Abdelwahed, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Wafaa Abdelsalam, MD

    Kafr Elsheikh university

    PRINCIPAL INVESTIGATOR

  • Shaimaa Zahra

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

January 1, 2022

Primary Completion

June 15, 2022

Study Completion

June 30, 2022

Last Updated

July 26, 2022

Record last verified: 2021-12

Locations

EG(1)