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Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury, Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Popliteal plexus block

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Peripheral nerve block, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aarhus University Hospital
The Regional Hospital in Horsens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with postoperative pain, NRS >3

Patients with postoperative pain, NRS ≤ 3

Arm Description

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

(approx. 90 patients)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with central knee pain

The percentage of patients with FTB reporting pain (NRS >3) localized in the center of the knee in the observation period

Onset time for PPB

Time from withdrawal of the needle until patient reports NRS ≤ 3

The effect of the PPB on cutaneous sensation

Tested on the lateral part of the lower leg (pinprick test)

The effect of the PPB on muscle strength

Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)

Full Information

NCT ID

NCT03130049

First Posted

April 23, 2017

Last Updated

January 18, 2018

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT03130049

Brief Title

Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 27, 2017 (Actual)

Primary Completion Date

December 4, 2017 (Actual)

Study Completion Date

December 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury, Postoperative Pain

Keywords

Peripheral nerve block, Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pilot study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with postoperative pain, NRS >3

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with postoperative pain, NRS ≤ 3

Arm Type

No Intervention

Arm Description

(approx. 90 patients)

Intervention Type

Procedure

Intervention Name(s)

Popliteal plexus block

Intervention Description

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

Primary Outcome Measure Information:

Title

The effect of the popliteal plexus block (PPB)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Percentage of patients with central knee pain

Description

The percentage of patients with FTB reporting pain (NRS >3) localized in the center of the knee in the observation period

Time Frame

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

Title

Onset time for PPB

Description

Time from withdrawal of the needle until patient reports NRS ≤ 3

Time Frame

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

Title

The effect of the PPB on cutaneous sensation

Description

Tested on the lateral part of the lower leg (pinprick test)

Time Frame

Baseline, 30 and 60 minutes after PPB

Title

The effect of the PPB on muscle strength

Description

Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)

Time Frame

Baseline, 60 minutes after PPB

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan M Jensen, MD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christian Jessen, MD

Organizational Affiliation

The Regional Hospital in Horsens

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

The Regional Hospital in Horsens

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28002228

Citation

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.

Results Reference

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PubMed Identifier

27685346

Citation

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.

Results Reference

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PubMed Identifier

25376972

Citation

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.

Results Reference

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PubMed Identifier

27442773

Citation

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.

Results Reference

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Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

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