Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injury; Postoperative Pain
• Interventions: Procedure: Popliteal plexus block

• Registration Number: NCT03130049
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-26
• Study Start: 2017-09-27
• Primary Completion: 2017-12-04
• Study Completion: 2017-12-04
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The effect of the popliteal plexus block (PPB)	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 Outcome Measures

Name	Time	Method
Onset time for PPB	Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB	Time from withdrawal of the needle until patient reports NRS ≤ 3
The effect of the PPB on cutaneous sensation	Baseline, 30 and 60 minutes after PPB	Tested on the lateral part of the lower leg (pinprick test)
The effect of the PPB on muscle strength	Baseline, 60 minutes after PPB	Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)
Percentage of patients with central knee pain	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

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark

The Regional Hospital in Horsens; 🇩🇰 Horsens, Denmark