NCT02853669

Brief Summary

Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (\*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply. This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy. This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 24, 2016

Last Update Submit

August 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain

    pain assessment using visual analogue scale

    2 hours

Study Arms (2)

group (A) lumber plexus block

EXPERIMENTAL

Ultrasound-guided Lumber plexus Block (30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation.

Procedure: Ultrasound-guided Lumber Plexus Block

Group (B) adductor canal block

EXPERIMENTAL

ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)

Procedure: adductor canal block

Interventions

(30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed were recorded. Ultrasound pictures (preinjection and postinjection) were obtained to verify proper local anesthetic placement.

group (A) lumber plexus block

ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)

Also known as: saphenous nerve block
Group (B) adductor canal block

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Age more than 25 and less than 80 were included

You may not qualify if:

  • Patients with known allergy to the medications to be given
  • ASA III, IV
  • Age less than 25 or more than 80
  • Dementia
  • Deafness
  • Psychological disease
  • Difficult to communicate
  • Cannot lay flat
  • INR more than 1.5
  • Low platelets (less than 100000/ml3) or with significant coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hassan Ali, LECTURER

    Anesthesia department, faculty of medicine ,Cairo university

    STUDY DIRECTOR

Central Study Contacts

Hassan Ali, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in anesthesia department Cairo university

Study Record Dates

First Submitted

July 24, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

August 3, 2016

Record last verified: 2016-07

Locations