NCT03130049

Brief Summary

The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2017

Completed
Last Updated

January 23, 2018

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

April 23, 2017

Last Update Submit

January 18, 2018

Conditions

Anterior Cruciate Ligament InjuryPostoperative Pain

Keywords

Peripheral nerve blockUltrasound

Outcome Measures

Primary Outcomes (1)

  • The effect of the popliteal plexus block (PPB)

    Evaluated as the percentage of patients with postoperative pain NRS \>3, dropping in pain score to NRS ≤ 3 after the PPB

    Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB

Secondary Outcomes (4)

  • Percentage of patients with central knee pain

    Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)

  • Onset time for PPB

    Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB

  • The effect of the PPB on cutaneous sensation

    Baseline, 30 and 60 minutes after PPB

  • The effect of the PPB on muscle strength

    Baseline, 60 minutes after PPB

Study Arms (2)

Patients with postoperative pain, NRS >3

EXPERIMENTAL

Patients reporting postoperative pain (NRS \>3) localized to the center of the knee (10 patients) will receive a popliteal plexus block

Procedure: Popliteal plexus block

Patients with postoperative pain, NRS ≤ 3

NO INTERVENTION

(approx. 90 patients)

Interventions

Popliteal plexus blockPROCEDURE

10 mL Marcain-adrenalin 5 mg/mL + 5 microgram/mL. Ultrasound-guided injection into the distal part of the adductor canal

Patients with postoperative pain, NRS >3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing ACL reconstruction on one of the two trial sites
  • Age ≥ 18
  • American Society of Anesthesiologists (ASA) status I-III
  • Informed consent

You may not qualify if:

  • Patients unable to cooperate
  • Patients not able to speak Danish or with other communication problems
  • Pregnancy
  • Contraindication towards any medical product used in the study
  • Preoperatively reduced sensation on the medial and lateral part of the lower leg
  • Patients with diabetes requiring medical treatment
  • Preoperative intake of opioids (dosed \> once daily)
  • ACL revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

The Regional Hospital in Horsens

Horsens, 8700, Denmark

Location

Related Publications (4)

  • Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.

    PMID: 28002228BACKGROUND

  • Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.

    PMID: 27685346BACKGROUND

  • Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.

    PMID: 25376972BACKGROUND

  • Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.

    PMID: 27442773BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesPain, Postoperative

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jan M Jensen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Christian Jessen, MD

    The Regional Hospital in Horsens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

September 27, 2017

Primary Completion

December 4, 2017

Study Completion

December 4, 2017

Last Updated

January 23, 2018

Record last verified: 2017-04

Locations

DK(2)