Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07077720
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2025-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMPARISON OF THE EFFECT OF DISTAL ADDUCTOR CANAL BLOCK COMBINED WITH GENICULAR NERVE BLOCK OR PERIARTICULAR INJECTION ON POSTOPERATIVE QOR-15 IN TOTAL KNEE ARTHROPLASTIES
Sponsor:
Bezmialem Vakif University
Organization:
Study Overview
Official Title:
COMPARISON OF THE EFFECT OF DISTAL ADDUCTOR CANAL BLOCK COMBINED WITH GENICULAR NERVE BLOCK OR PERIARTICULAR INJECTION ON POSTOPERATIVE QOR-15 IN TOTAL KNEE ARTHROPLASTIES: A RANDOMIZED CONTROLLED STUDY
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective: This study compares the effects of genicular nerve block (GNB) and periarticular injection (PAI), added to distal adductor canal block (ACB), on postoperative recovery quality (QoR-15), morphine use, and pain scores after total knee arthroplasty (TKA).
Methods: Sixty patients received spinal anesthesia and distal ACB, then were randomized to GNB (Group G, n=30) or PAI (Group P, n=30). QoR-15, morphine consumption, VAS pain scores, nausea/vomiting, and side effects were evaluated.
Methods: Sixty patients received spinal anesthesia and distal ACB, then were randomized to GNB (Group G, n=30) or PAI (Group P, n=30). QoR-15, morphine consumption, VAS pain scores, nausea/vomiting, and side effects were evaluated.
Detailed Description:
Objective: Total knee arthroplasty (TKA) is a common surgical procedure for knee pathologies of various etiologies, where postoperative pain management is critical for early mobilization and rehabilitation. Different blockade techniques targeting the femoral, obturator, and sciatic nerves, which provide sensory innervation to the knee, are evaluated in terms of analgesic efficacy and preservation of motor function. The adductor canal block (ACB) targets the saphenous nerve without affecting motor function, whereas periarticular injection (PAI) and genicular nerve block (GNB) provide more comprehensive analgesia by blocking other branches of the femoral nerve as well as the obturator and sciatic nerves. This study aims to compare the effects of GNB and PAI, applied in addition to distal ACB, on postoperative recovery quality measured by the Quality of Recovery-15 (QoR-15) score, morphine consumption, and pain scores in patients undergoing TKA.
Materials and Methods: This single-center, randomized, prospective study included patients over 18 years of age with ASA physical status I-III who were scheduled for total knee arthroplasty under spinal anesthesia. All patients received spinal anesthesia with 15 mg isobaric bupivacaine combined with 100 mcg intrathecal morphine. Additionally, all patients underwent ultrasound-guided distal adductor canal block. Patients were randomized into Group G (n=30) and Group P (n=30). Group G received preoperative genicular nerve block (5+5+5 ml of 0.25% bupivacaine), whereas Group P received intraoperative periarticular injection administered by the surgical team, consisting of 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin and 110 mg bupivacaine. The primary outcome measure was the quality of recovery evaluated by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours postoperatively. Secondary outcomes included morphine consumption at 2., 6., 12. and 24 hours postoperatively, resting and movement Visual Analog Scale (VAS) pain scores, postoperative nausea and vomiting (PONV) scores, and the incidence of adverse effects such as respiratory depression, urinary retention, and pruritus.
Materials and Methods: This single-center, randomized, prospective study included patients over 18 years of age with ASA physical status I-III who were scheduled for total knee arthroplasty under spinal anesthesia. All patients received spinal anesthesia with 15 mg isobaric bupivacaine combined with 100 mcg intrathecal morphine. Additionally, all patients underwent ultrasound-guided distal adductor canal block. Patients were randomized into Group G (n=30) and Group P (n=30). Group G received preoperative genicular nerve block (5+5+5 ml of 0.25% bupivacaine), whereas Group P received intraoperative periarticular injection administered by the surgical team, consisting of 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin and 110 mg bupivacaine. The primary outcome measure was the quality of recovery evaluated by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours postoperatively. Secondary outcomes included morphine consumption at 2., 6., 12. and 24 hours postoperatively, resting and movement Visual Analog Scale (VAS) pain scores, postoperative nausea and vomiting (PONV) scores, and the incidence of adverse effects such as respiratory depression, urinary retention, and pruritus.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: