The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198403
• Other study ID #: 2017-001644-35
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2017
• Last updated: September 28, 2017
• Start date: August 1, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: September 2017
• Source: Regionshospitalet Silkeborg
• 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 after total knee arthroplasty

Description:

Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 28, 2017
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing total knee arthroplasty in spinal anesthesia

• age > or = 18 years

• American Society of Anesthesiologists (ASA) status I-III

• Informed consent

Exclusion Criteria:

• Patients unable to cooperate

• Patients not able to speak Danish

• Pregnancy

• Contraindication towards ana Medical product used in the study

• Preoperatively reduced sensation on the medial and lateral part of the lower leg

• Patients with diabetic requiring Medical treatment

• Preoperative daily intake of opioids

Related Conditions & MeSH terms

• Popliteal Plexus Block
• Total Knee Arthroplasty

Intervention

Drug:
• Bupivacaine-epinephrine
Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.

Locations

Country	Name	City	State
Denmark	Silkeborg Regionalhospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with postoperative pain NRS	Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS = or < 3 after the PPB	0 - 60 minutes
Secondary	Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3	Percentage of patients having a FTB, reporting postoperative pain NRS >3	Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)
Secondary	Onset time of PPB	Time from end of injection of PPB to NRS = or < 3	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Secondary	Turn off time of spinal anesthesia	Time from arrival in PACU to normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) on the lateral part of the thigh and lateral part of the lower leg	Time from arrival in PACU and during maximum 6 hours
Secondary	Correlation between normal cutaneous sensation and developing of pain	Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS>3)	From arrival in PACU and during maximum 6 hours
Secondary	The effect of the PPB on cutaneous sensation	Tested on the lateral part of the lower leg	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Secondary	The effect of the PPB on muscle strength of the foot	Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer	Baseline and 1 hour after PPB