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临床试验/NCT05648708
NCT05648708已完成不适用

Comparing Combined Adductor Canal & Sciatic Nerve Block and Femoral & Sciatic Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement Surgery; A Prospective, Randomized, Controlled Study

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)

研究概览

简要总结

Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. Total knee replacement (TKR) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life.

Pain can be very severe after TKR surgery, which is very common in the middle and elderly patient population today. In the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. Effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain.

In this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo TKR surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.

详细描述

As a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval.

68 patients who meet the inclusion criteria will be included in our study. Patients will be randomized and divided into 2 groups. Accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages of 40-85
  • ASA I-III
  • Patients who will undergo total knee replacement surgery under general anesthesia

排除标准

  • Patients with deformity and pathology in the thigh region
  • Clinically known local anesthetic allergy
  • Clinically diagnosis of opioid, alcohol and substance dependence
  • Patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia
  • Morbid obesity (body mass index> 40 kg m2)

研究组 & 干预措施

Group AS

Active Comparator

The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia

干预措施: Combine Adductor Canal & Sciatic Nerve Block (Procedure)

Group AS

Active Comparator

The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia

干预措施: Bupivacaine and prilocaine hydrochloride (Drug)

Group FS

Active Comparator

The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia

干预措施: Combine Femoral & Sciatic Nerve Block (Procedure)

Group FS

Active Comparator

The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia

干预措施: Bupivacaine and prilocaine hydrochloride (Drug)

结局指标

主要结局

The primary outcome measure of the study is the patients' postoperative pain scores (NRS)

时间窗: 72 hours postoperatively

Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 48, 72th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable

次要结局

  • The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively(Three days postoperatively)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gokhan Sertcakacilar, MD

Principal investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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