跳至主要内容
临床试验/NCT06095908
NCT06095908已完成不适用

The Effect of Ultrasound-Guided Bilateral Rectus Sheath Block Versus Wound Infiltration on Postoperative Pain in Gynecooncological Patients Undergoing Laparotomy With Midline Incision: Randomized Controlled Triple Blinding Study

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月15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
30
试验地点
1
主要终点
Evaluate patients' postoperative pain

研究概览

简要总结

Postoperative pain is a serious problem in gynecological oncology patients who underwent median vertical incision. The aim of our study is to compare ultrasound guided bilateral rectus sheath block and local anesthetic wound infiltration application in postoperative pain control.

详细描述

This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2023/514/257/31, Date: 29/05/2023) and was performed in accordance with the Declaration of Helsinki.. Between June and September 2023, ultrasound guided bilateral rectus sheath block or local anesthesia administered to the patients in the gynecological oncology operating room of the University of Health Sciences Kartal Dr Lutfi Kırdar City Hospital at the end of the surgery. In the postoperative period, the pain level of the patients was recorded with the numerical rating scale at 2, 6, 12 and 24 hours by an anesthesiologist who was unaware of the application. The data were entered into the table by an anesthesiologist who did not know which application was performed. Thus, data were recorded using a randomized triple blinding method in which the patient, the researcher, and the recording staff were blinded.

All patients underwent preoperative evaluation one day before surgery and written informed consent was obtained for participation for the study. The procedure to be performed on the patients was planned in accordance with the randomization made by the statistician. The anesthesiologist who would perform the intervention participated in the study blindly to the drugs and groups. Patients in Group I underwent postoperative ultrasound-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total). For the patients in Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). At the end of the surgery, 100 mg tramadol iv and paracetamol 1mg/kg iv were administered to both groups as analgesics.

Pain, ranging from 0 (no pain) to 10 (worst imaginable), was queried by another anesthesiologist who was blind to the procedure. 2*1 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward, but the first application time was planned by questioning the patient's pain. Rescue analgesia with tramadol was administered if the patient ranged the pain >4 . Pain was measured at the 2nd, 6th, 12th and 24th hours postoperatively, and tramadol consumption was recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • electively gynecooncological surgery patients with median incision
  • ASA II-III,
  • between 18-65 years

排除标准

  • ASA IV and above
  • over 65 - under 18 years of age
  • previous laparotomy
  • allergy to local anesthetics

研究组 & 干预措施

'rectus sheath block'

Patients in Group I underwent postoperative USG-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total).

干预措施: Bupivacain (Drug)

'wound infiltration'

Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total).

干预措施: Bupivacain (Drug)

结局指标

主要结局

Evaluate patients' postoperative pain

时间窗: postoperative 2,6,12,24 th hours

The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of bilateral rectus sheath block and wound infiltration in gyneco-oncological patients undergoing laparatomy with midline incision. Numeric rating scale (NRS) of 1-10 used for the assessment of postoperative pain.

次要结局

  • Evaluate patients' total analgesic consumption(postoperative 24 hours)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Merve Bulun Yediyıldız

Specialist Dr

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

Loading locations...

相似试验