Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130049
• Other study ID #: Protokol_PPB_ACL_21042017
• Status: Completed
• Phase: N/A
• First received: April 23, 2017
• Last updated: January 18, 2018
• Start date: September 27, 2017
• Est. completion date: December 4, 2017

Study information

• Verified date: April 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 4, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C
Denmark	The Regional Hospital in Horsens	Horsens

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Bendtsen TF, Moriggl B, Chan V, Børglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. — View 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. — View 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. — View Citation

Wong WY, Bjørn S, Strid JM, Børglum 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Secondary	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	Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
Secondary	Onset time for PPB	Time from withdrawal of the needle until patient reports NRS = 3	Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Secondary	The effect of the PPB on cutaneous sensation	Tested on the lateral part of the lower leg (pinprick test)	Baseline, 30 and 60 minutes after PPB
Secondary	The effect of the PPB on muscle strength	Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)	Baseline, 60 minutes after PPB