Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- IPACK block with Bupivacaine 0.25% with adrenaline
- Conditions
- Pain, Acute
- Sponsor
- Germans Trias i Pujol Hospital
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Pain at rest
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.
There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.
Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.
Investigators
Dinu
Principal Investigator
Germans Trias i Pujol Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
- •Locoregional anesthesia
- •Age equal to or greater than 18 years
- •Consent to participate in the study
Exclusion Criteria
- •Age under 18 years old
- •General anesthesia
- •Allergy to local anesthetics
- •Severe kidney failure (Cr ≥ 2mg / dL)
- •Chronic opioid use (over 3 months)
- •Chronic pregabalin / gabapentin use (more than 3 months)
- •Psychiatric illness that may interfere with the evaluation or follow-up
Arms & Interventions
Echo-guided IPACK block
IPACK block using 0.25% bupivacaine 15mL with adrenaline once.
Intervention: IPACK block with Bupivacaine 0.25% with adrenaline
Echo-guided sciatic block
Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once.
Intervention: IPACK block with Bupivacaine 0.25% with adrenaline
Outcomes
Primary Outcomes
Pain at rest
Time Frame: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at movement
Time Frame: 6 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain with movement
Time Frame: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Motor block
Time Frame: 48 hours after surgery
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Secondary Outcomes
- Discharge days(Days)
- Ambulation time(Up to 24 hours)
- Opioids dose(48 hours after surgery)
- Patient satisfaction(24 hours after surgery)