Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.
- Conditions
- Pain, AcuteKnee OsteoarthritisAnesthesia
- Interventions
- Drug: IPACK block with Bupivacaine 0.25% with adrenaline
- Registration Number
- NCT06514365
- Lead Sponsor
- Germans Trias i Pujol Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Echo-guided IPACK block IPACK block with Bupivacaine 0.25% with adrenaline IPACK block using 0.25% bupivacaine 15mL with adrenaline once. Echo-guided sciatic block IPACK block with Bupivacaine 0.25% with adrenaline Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once.
- Primary Outcome Measures
Name Time Method Pain at movement 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 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 rest 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 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 Outcome Measures
Name Time Method Opioids dose 48 hours after surgery Measured in milligrams of intravenous morphine hydrochloride daily.
Discharge days Days Time to discharge measured in days
Ambulation time Up to 24 hours Time to ambulation (measured in hours) from discharge from URPA
Patient satisfaction 24 hours after surgery Patient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction.
Trial Locations
- Locations (1)
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain