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临床试验/NCT07077720
NCT07077720已完成不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative 24th hour qor-15

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients scheduled for knee arthroplasty
  • •Patients classified as ASA I, II, or III
  • •Patients aged 18 years and older

排除标准

  • •Patients with a known allergy to any of the drugs used in the study
  • •Presence of infection near the puncture site
  • •History or presence of neurological disorders (e.g., transient ischemic attack, syncope, dementia, etc.)
  • •Known coagulation disorders
  • •History of alcohol or substance abuse
  • •Impaired consciousness
  • •Chronic opioid use equal to or exceeding 60 mg of oral morphine equivalents per day
  • •Pre-existing neuropathic pain
  • •Hepatic failure, renal failure, or cardiac insufficiency
  • •Uncontrolled diabetes mellitus
  • •Pregnant or breastfeeding women
  • •Refusal or inability to provide written informed consent

研究组 & 干预措施

Grup G

Active Comparator

Genicular nerve block

干预措施: genicular nerve block (Procedure)

Grup G

Active Comparator

Genicular nerve block

干预措施: Addukctor canal block (Procedure)

Grup G

Active Comparator

Genicular nerve block

干预措施: Spinal Anesthesia with Bupivacaine and Morphine (Procedure)

Grup P

Active Comparator

Periarticular injecrion

干预措施: periarticular injection (Procedure)

Grup P

Active Comparator

Periarticular injecrion

干预措施: Addukctor canal block (Procedure)

Grup P

Active Comparator

Periarticular injecrion

干预措施: Spinal Anesthesia with Bupivacaine and Morphine (Procedure)

结局指标

主要结局

Postoperative 24th hour qor-15

时间窗: Postoperative 24th hour

Postoperative 24th hour qor-15 score

次要结局

  • Postoperative 2nd, 6th, 12th, and 24th hour resting VAS score(Postoperative 2nd, 6th, 12th, and 24th hour)
  • Postoperative 2nd, 6th, 12th, and 24th hour adverse effects(Postoperative 2nd, 6th, 12th, and 24th hour)
  • Postoperative 2nd, 6th, 12th, and 24th hour morphine consumption(Postoperative 2nd, 6th, 12th, and 24th hour)
  • Postoperative 2nd, 6th, 12th, and 24th hour movement VAS score(Postoperative 2nd, 6th, 12th, and 24th hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Çağrı Sarıarslan

research assistant

Bezmialem Vakif University

研究点 (1)

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