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Clinical Trials/NCT03130049
NCT03130049
Completed
Not Applicable

The Effect of the Popliteal Plexus Block on Postoperative Pain After Reconstruction of the Anterior Cruciate Ligament

University of Aarhus2 sites in 1 country15 target enrollmentSeptember 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injury
Sponsor
University of Aarhus
Enrollment
15
Locations
2
Primary Endpoint
The effect of the popliteal plexus block (PPB)
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

Postoperative pain following ACL reconstruction can be alleviated with an ultrasound-guided femoral triangle block (FTB). However, it is the investigators' observation that 10-20 % of the patients still complain of intense pain localized in the center of the knee. Cadaver dissection studies have shown that an injection into the distal part of the adductor canal will spread to the popliteal fossa, and one dissection study showed consistent spread to the popliteal plexus. The study team hypothesized that a PPB will reduce the postoperative pain, when it is used as a supplement to the FTB in patients undergoing ACL reconstruction.

Registry
clinicaltrials.gov
Start Date
September 27, 2017
End Date
December 4, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

The effect of the popliteal plexus block (PPB)

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

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

Secondary Outcomes

  • 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)
  • Percentage of patients with central knee pain(Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU))

Study Sites (2)

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