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NCT Number: NCT03130049

Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

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

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Popliteal plexus block

Procedure

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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