NCT05271188

Brief Summary

A comparison between IPACK block and adductor canal block in post operative pain management

Trial Health

35
At Risk

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 2022

Status
unknown

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

First Submitted

Initial submission to the registry

February 14, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

February 14, 2022

Last Update Submit

March 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the time of first pain sensation requiring analgesia

    If intervention which is adductor canal block or lPACK block is effective in postoperative pain control that can decrease the lV analgesic agents

    24 hours

Study Arms (2)

Group 1 who will receive IPACK block

ACTIVE COMPARATOR

This group of patients will receive IPACK block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements

Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsule

Group 2 who will receive adductor canal block

ACTIVE COMPARATOR

This group of patients will receive adductor canal block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements

Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsule

Interventions

Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function \[8\]. Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which is moderate to severe in intensity \[9, 10\]. The recent technique of an ultrasound (US)-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown to provide significant posterior knee analgesia without affecting the common peroneal nerve (CPN) \[11\]. We postulated that IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB

Also known as: Adductor canal block
Group 1 who will receive IPACK blockGroup 2 who will receive adductor canal block

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40 - 60 years.
  • American Society of Anesthiologist class ( ASA) I - III
  • BMI 18-35 kg/m2
  • Scheduled for primary unilateral open wedge high tibial osteotomy

You may not qualify if:

  • Known allergy to local anesthetics
  • Contraindication to local anesthetics injection e.g. infection at the site of injection
  • Contraindication to spinal anesthesia e.g. coagulopathy.
  • Patients with pre-existing motor or sensory deficits in lower extremities.
  • Insulin or noninsulin dependent diabetes mellitus.
  • systemic corticosteroid use within 30-days of surgery
  • difficulties in comprehending visual analog scale (VAS) pain scores
  • history of arrhythmia or seizures
  • severe renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Salwa Hussein, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abd elraheem Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups of people who are undergoing open wedge high tibeal osteotomy aged between 40 and 60 yrs old not diabetic and neurologically free
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 8, 2022

Study Start

March 15, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share