Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

January 18, 2018 updated by: University of Aarhus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital
      • Horsens, Denmark, 8700
        • The Regional Hospital in Horsens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing ACL reconstruction on one of the two trial sites
  • Age ≥ 18
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with postoperative pain, NRS >3
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
10 mL Marcain-adrenalin 5 mg/mL + 5 microgram/mL. Ultrasound-guided injection into the distal part of the adductor canal
No Intervention: Patients with postoperative pain, NRS ≤ 3
(approx. 90 patients)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with central knee pain
Time Frame: Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
The percentage of patients with FTB reporting pain (NRS >3) localized in the center of the knee in the observation period
Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
Onset time for PPB
Time Frame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Time from withdrawal of the needle until patient reports NRS ≤ 3
Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
The effect of the PPB on cutaneous sensation
Time Frame: Baseline, 30 and 60 minutes after PPB
Tested on the lateral part of the lower leg (pinprick test)
Baseline, 30 and 60 minutes after PPB
The effect of the PPB on muscle strength
Time Frame: Baseline, 60 minutes after PPB
Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)
Baseline, 60 minutes after PPB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jan M Jensen, MD, Aarhus University Hospital
  • Principal Investigator: Christian Jessen, MD, The Regional Hospital in Horsens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2017

Primary Completion (Actual)

December 4, 2017

Study Completion (Actual)

December 4, 2017

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protokol_PPB_ACL_21042017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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