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临床试验/NCT07626346
NCT07626346招募中不适用

The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年6月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
1

研究概览

简要总结

Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.

Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.

The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.

详细描述

Patients meeting the inclusion criteria will be randomly assigned to receive either:

Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)

Preoperative assessment:

Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.

The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain

研究设计

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

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

  • Male or female patients aged 18-65 years
  • Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
  • American Society of Anesthesiologists (ASA) physical status I-II

排除标准

  • Patient refusal.
  • hypersensitivity or contraindication to dexmedetomidine
  • History of allergy or intolerance to study medications
  • Chronic opioid use (>3 months)
  • Pregnancy or breastfeeding
  • Severe renal or hepatic impairment
  • Patient's with coagulopathy disorders

研究组 & 干预措施

PENG block with bupivacaine

Experimental

ultrasound-guided Pericapsular nerve group block with bupivacaine

干预措施: nerve block (Procedure)

PENG block with bupivacaine and dexmedetomidine

Experimental

ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine

干预措施: nerve block (Procedure)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed nabih youssef

lecturer of anethesia

Kasr El Aini Hospital

研究点 (1)

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