Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.
NCT Number: NCT06514365
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute|Knee Osteoarthritis|Anesthesia
Interventions: DRUG: IPACK block with Bupivacaine 0.25% with adrenaline
Sponsor: Germans Trias i Pujol Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-06-10
Completion Date: 2024-08-01
Locations: Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain

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.

Primary Outcome Measures: Pain at rest, Measured by the numerical visual scale at 6 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., 6 hours after surgery|Pain at rest, Measured by the numerical visual scale at 24 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., 24 hours after surgery|Pain at rest, 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., 48 hours after surgery|Pain at movement, 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., 6 hours after surgery|Pain with movement, 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., 24 hours after surgery|Pain with movement, 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., 48 hours after surgery|Motor block, 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))., 6 hours after surgery|Motor block, 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))., 24 hours after surgery|Motor block, 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))., 48 hours after surgery
Secondary Outcome Measures: Opioids dose, Measured in milligrams of intravenous morphine hydrochloride daily., 6 hours after surgery|Opioids dose, Measured in milligrams of intravenous morphine hydrochloride daily., 24 hours after surgery|Opioids dose, Measured in milligrams of intravenous morphine hydrochloride daily., 48 hours after surgery|Discharge days, Time to discharge measured in days, Days|Patient satisfaction, Patient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction., 24 hours after surgery|Ambulation time, Time to ambulation (measured in hours) from discharge from URPA, Up to 24 hours