Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05960422 |
Other study ID # |
EzgiPOLAT |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
February 10, 2022 |
Study information
Verified date |
July 2023 |
Source |
Istanbul Medeniyet University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this observational study is to determine the effect of adding adductor canal
block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative
sedation need, tourniquet pain, return time of motor block, and postoperative pain in
patients undergoing hallux valgus correction surgery. The main question it aims to answer
are:
- Does peroperative pain decrease?
- Do patient-surgeon satisfaction increase? The patients were divided into two groups, the
Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal
Block (PSB + ACB) group.
Description:
Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB),
popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients
scheduled for hallux valgus correction operations, in the American Society of
Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned
as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml
0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and
nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to
the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with
coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic
drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities,
peripheral artery disease, mental retardation and those who did not give consent to study
were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the
blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet
pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and
analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to
group distribution .