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临床试验/NCT04849468
NCT04849468Unknown2 期

Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
15
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

The research will be carried out in order to test the effect of Intramuscular (IM) Diclofenac, administered as preemptive analgesic with minimal effective dose spinal anesthesia in perianal surgeries, on prolonging the time to first request for analgesic and lowering analgesic consumption. Investigators hypothesized that using IM Diclofenac in this surgery will postpone the time to first analgesic request and will decrease the consumption of post-operative analgesics. Our method includes dividing the patients into control and study groups and recording the first analgesic request and post-operative analgesic consumption after surgery and comparing the results.

详细描述

Effective control of post-operative pain is an issue that has been repeatedly emphasized and has received an increasing amount of attention in the past few years (1, 2). Opioids, despite their side effects, are still the main cornerstone in managing acute postoperative pain (3). Preemptive analgesia refers to the administration of effective analgesia prior to surgical trauma. The main mechanism of preemptive analgesia is desensitization of the central nervous system and prevention of pain before its onset. (3). Non-opioid preemptive analgesics are commonly used to increase analgesic efficacy and patient satisfaction as well as to reduce opioid consumption and side effects. Saddle anesthesia is a selective spinal anesthesia that is commonly used for perianal surgeries (4-7).

Investigators previously performed a prospective up-down sequential allocation study to evaluate the minimum effective dose of hyperbaric bupivacaine that is needed for inducing a satisfactory and reliable saddle block for perianal surgeries that was restricted to the most caudal spinal nerve roots (S4-coccygeal) that supply the perianal region (8). Although the block produced no motor block in the lower limbs (thus allowing early ambulation), rapid sensory recovery resulted in early request of analgesia and increased opioid consumption. In this prospective, randomized, double blinded, placebo controlled clinical trial, Investigators hypothesize that a single dose of IM diclofenac administered before spinal anesthesia, will decrease postoperative pain, and delay and reduce postoperative analgesic requirement in patients undergoing minor perianal surgeries under minimal effective-dose bupivacaine saddle block

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
Double (Participant, Outcomes Assessor)

盲法说明

The studied drugs will be prepared immediately before injection by an anesthesiologist blinded to the study methodology and will be administered by a second blinded anesthesiologist patients and assessor also will be unaware of the type of group

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I and II scheduled for elective outpatient perianal surgery in the lithotomy position (hemorrhoidectomy, fistulectomy)

排除标准

  • contraindications to regional anesthesia, bleeding disorders, are morbidly obese, suffer from mental health problems, are on analgesic medication or psychotropic drugs, have a known history of allergy to amide local anesthetic drugs, if there is a language barrier, or if they are unwilling to participate

研究组 & 干预措施

Diclofenac (D) group

Active Comparator

Diclofenac (D) group which will receive 75 mg (3ml) intramuscular Diclofenac in a 5ml syringe in the holding area 30 minutes before spinal block

干预措施: Declofenac (Drug)

Saline (S) group

Active Comparator

Saline (S) group which will receive 3ml intramuscular saline in a similar 5ml syringe in the holding area 30 minutes before spinal block

干预措施: saline (Drug)

结局指标

主要结局

postoperative pain

时间窗: up to 24 hours

visual analogue scale

Time to first analgesia request

时间窗: up to 24 hours

first request of analgesia by the patient

total consumption of analgesia

时间窗: 24 hours

total consumption of tramadol in mg

次要结局

未报告次要终点

研究者

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

Hitham Mohammed Aly Elsayed

Anesthesia consultant

Imam Abdulrahman Bin Faisal University

研究点 (1)

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