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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03198403
Other study ID # 2017-001644-35
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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