跳至主要内容
临床试验/NCT04855019
NCT04855019已完成不适用

Comparison of Combined Suprascapular and Axillary Nerve Blocks With Periarticular Injection for Analgesia in Arthroscopic Shoulder Surgery

Namik Kemal University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change from the baseline 11 point NRS (numeric rating Scala) Scala

研究概览

简要总结

Postoperative multimodal analgesia methods occupy an essential place in modern anesthesia. The postoperative results of opioid analgesia are now at the bottom of the current problems due to its side effects. Longer-acting local anesthetics are now effective agents of analgesia.

Investigators aimed to compare the two routine methods. Ultrasonic nerve blocks are the most important of multimodal analgesia in modern anesthesia. Suprascapular and axillary nerve blocks are routinely used as a safe method. It is a routine method used by periarticular local anesthetic surgeons.

İnvestigators decided to compare which method effectively follows these two methods with the postoperative 24 pain scale method.

详细描述

This randomized trial aims to assess if a combined suprascapular-axillary nerve block (CSAB) to periarticular injection (PI) treated pain after arthroscopic shoulder surgery. Secondary endpoints included opioid consumption, discomfort associated with muscle weakness, and patient satisfaction.

sixty patients undergoing arthroscopic shoulder surgery will be randomized to receive ultrasound-guided CSAB (n = 30) or PI (n = 30). Pain intensity at rest and discomfort were recorded upon arrival in the recovery room, discharge to the ward, and at 4, 8, and 24 hours after surgery. Tramadol consumption was recorded for the first 24 hours. Patient satisfaction data will be recorded on the second postoperative day.

Using a computer-generated random allocation sequence (created by the study statistician), patients will randomly be assigned to ultrasound-guided SAB (n = 30) or PI(n = 30). Allocation numbers will be sealed in an opaque envelope opening in sequence by an independent anesthesiologist who will not assess outcomes. Outcome assessors will be blinded to treatment allocation.

After eligible patients are identified from the registry, patient charts were prospectively a blind orthopedist would collect data. Demographic data including sex, age, body mass index, surgical procedure, and complications will be recorded. Primary outcome measures were numeric rating scale pain scores and 24-hour postoperative opioid consumption. Pain scores will be recorded immediately before surgery, immediately following surgery in the postanesthesia recovery unit, and 24 hours postoperatively. Total opioid consumption will also be recorded for the first 24 hours following surgery. Secondary outcome measures included length of surgery, operating room time, perioperative anesthesia time, blood loss, hospital length of stay, and intraoperative and 30-day postoperative complication rates. Postoperative complications were further categorized as nerve-related, cardiopulmonary, and musculoskeletal (fracture or tendon rupture).

Statisticians will compare statistics between groups using a 2-sample t-test for normally distributed variables. The Wilcoxon rank-sum test will be used for non-normally distributed variables. A general linear model with correlated errors was used to account for repeated pain score assessments over time for each subject. The Fisher exact test will be used for categorical variables. Summary statistics will be reported as the mean and standard deviation for data analyzed using the 2-sample t-test and general linear models. The median and 25th and 75th percentiles will be reported for the Wilcoxon rank-sum test. The frequency (i.e., n) and percentage will be reported for data analyzed using the Fisher exact test. A P value of .05 will be designated as the threshold for statistical significance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being in the age range of 18-65
  • agree to participate in the study

排除标准

  • diabetic patients
  • chronic opioid use
  • patients with sensitivity to local anesthetics
  • patients with neuropathy
  • Patients who cannot use the PCA
  • cases returning to open surgery

结局指标

主要结局

Change from the baseline 11 point NRS (numeric rating Scala) Scala

时间窗: 0 to 24 hours

Possible scores range from 0 (no pain) to 10 ( worst possible pain). Change for 24 Hours.

Total opioid consumption, from the moment of exit from the operation to the 24th hour

时间窗: 0 to 24 hours

Each patient will be fitted with a patient controlled analgesia (PCA) device. The total tramadol requirement for both groups will be calculated.

次要结局

  • nausea and vomiting(0 to 24 hours)

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayhan ŞAHİN

Principal Investigator

Namik Kemal University

研究点 (2)

Loading locations...

相似试验