The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty

NCT ID: NCT03198403

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-09-28

Brief Summary

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The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

Detailed Description

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Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

Conditions

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Popliteal Plexus Block Total Knee Arthroplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pilot Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Popliteal plexus block

Patients with an FTB, reporting postoperative pain (NRS \> 3) will have a popliteal plexus block

Group Type EXPERIMENTAL

Bupivacaine-epinephrine

Intervention Type DRUG

Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.

No intervention

Patients with postoperative pain NRS \< or = 3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine-epinephrine

Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing total knee arthroplasty in spinal anesthesia
* age \> or = 18 years
* American Society of Anesthesiologists (ASA) status I-III
* Informed consent

Exclusion Criteria

* Patients unable to cooperate
* Patients not able to speak Danish
* Pregnancy
* Contraindication towards ana Medical product used in the study
* Preoperatively reduced sensation on the medial and lateral part of the lower leg
* Patients with diabetic requiring Medical treatment
* Preoperative daily intake of opioids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Silkeborg

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Runge

Consultant anesthetist, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Runge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Silkeborg Regionalhospital

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2017-001644-35

Identifier Type: -

Identifier Source: org_study_id