Clinical trial NCT03130049: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Postoperative Pain
Keywords: Peripheral nerve block
Ultrasound
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The effect of the popliteal plexus block (PPB)
timeFrame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Secondary outcomes:
measure: Percentage of patients with central knee pain
timeFrame: Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
measure: Onset time for PPB
timeFrame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
measure: The effect of the PPB on cutaneous sensation
timeFrame: Baseline, 30 and 60 minutes after PPB
measure: The effect of the PPB on muscle strength
timeFrame: Baseline, 60 minutes after PPB
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Horsens
country: Denmark
facility: The Regional Hospital in Horsens
Study officials:
affiliation: Aarhus University Hospital
name: Jan M Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Regional Hospital in Horsens
name: Christian Jessen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.