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临床试验/NCT05342259
NCT05342259已完成不适用

Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision

Ain Shams University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年5月25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
81
试验地点
1
主要终点
pain scoring using the Wong Baker scale

研究概览

简要总结

in order to eliminate fear and anxiety. Regional techniques are more effective than systemic opioids, non steroidal anti-inflammatory drugs, and acetaminophen for postoperative analgesia in circumcision, The most preferred techniques are dorsal penile nerve block and caudal block.

Objective: To investigate the effectiveness of post operative analgesia and complications among dorsal penile nerve block, caudal block and the combination of both.

Patients and Methods: Our study was carried out to compare the effectiveness, duration of post-operative analgesia, and the complications among dorsal penile nerve block (DPNB), caudal nerve block (CNB) and the combination of both. This study will carrey out on 81 male patients, aged from 3-12 years old & undergoing circumcision. The patients were divided into 3 groups, each is composed of 27 patients; group 1 including DPNB patients, group 2 including CNB patients and group 3 for combined block. This study compared between the three groups regarding the intra-operative vital data (HR,BP), post-operative VAS scores and the complications (nausea, vomiting, urinary retention, itching, constipation & CNS depression).

详细描述

Cases were subdivided into three groups: Group 1: included dorsal penile block patients. Group 2: included caudal block patients. Group 3: included combined block patients.

Circumcision was performed under general anesthesia and dorsal slit technique was used.

Study procedure:

General anesthesia was induced and maintained by inhalation of sevoflurane in oxygen mixed with air gas flow. A 22-G intravenous (i.v.) cannula was placed after induction. Spontaneous respiration was maintained via a selected laryngeal mask airway, and the inhaled sevoflurane was modified and maintained as 0.8 to 1.0MAC.

Block techniques:

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
Male
接受健康志愿者
是

入选标准

  • •Age: 3-12 years.
  • •ASA I & II.

排除标准

  • •Patient's refusal.
  • •Contraindications to regional blocks as bleeding disorders and skin infections.
  • •Drug hypersensitivity.
  • •Failure of achieving block.

研究组 & 干预措施

dorsal penile block patients

Active Comparator

干预措施: Dorsal penile nerve block (Procedure)

caudal block patients

Active Comparator

干预措施: Caudal nerve block /neuroaxial (Procedure)

combined block patients

Active Comparator

干预措施: Combined caudal and dorsal penile nerve block (Procedure)

结局指标

主要结局

pain scoring using the Wong Baker scale

时间窗: 24th hour postoperatively

scale at 24th hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

pain scoring using the Wong Baker scale

时间窗: 1st hour postoperatively

scale at 1st hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

pain scoring using the Wong Baker scale

时间窗: 3rd hour postoperatively

scale at 3rd hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

次要结局

  • complications(one day after operation)
  • intra-operative mean arterial blood pressure (mmhg)(intraoperatively)
  • : intra-operative heart rate (beats/ minuts).(scale at 24th hour post operative)
  • : intra-operative heart rate (beats/ minuts).(scale at 1st hour post operative)
  • : intra-operative heart rate (beats/ minuts).(scale at 3rd hour post operative)

研究者

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

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (1)

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