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临床试验/NCT03694639
NCT03694639Unknown4 期

CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome

Mansoura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
4 期
入组人数
40
试验地点
2
主要终点
Participant satisfaction reporting scale (PSRS)

研究概览

简要总结

Background:Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area.In this study, the investigators evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome.

Method: Forty patients were randomly allocated into 2 groups: Group A (n=20) where patients received pregabaline 150 mg twice daily. Group B (n=20) where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.

详细描述

Introduction:

Phantom pain syndromes are mostly recorded after amputation of limbs, but it may affect any part of the body (visceral or somatic) has sensory perception following its removal as breast, teeth or rectum.

Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area characterized as pins, needles, stinging, and burning occurring mostly in sitting positions.

phantom rectum pain syndrome is rarely reported and it is varies from individual to individual. The presence of preoperative rectal pain has a good correlation for the development of postoperative phantom pain.

The pathophysiological mechanisms of phantom phenomena is still unknown but it is neuropathic in nature and believed that it is initiated by changes arising at the peripheral, spinal and supraspinal level leading to central reorganization in additional to the psychogenic factor.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.

排除标准

  • those who refused to share
  • evidence of local infection at the puncture site
  • allergy to drugs used
  • patients with bleeding tendency or coagulopathy, renal or hepatic failure, cardiac patients,
  • bony abnormality and local malignant recurrence or lower vertebral metastasis.

结局指标

主要结局

Participant satisfaction reporting scale (PSRS)

时间窗: two months

it is 5 item self questionnaire1. How well was your pain problem explained to you during treatment?2. Did you agree with the types of treatments and recommendations that you received? 3. How satisfied were you with the care that you received in the Spine Care Center/ Anesthesiology Clinic? 4. Rate your overall improvement since starting treatment: 5. Rate your level of satisfaction with your improvement since starting treatment.

numerical rating scale

时间窗: two months

from 0 to 10 as 0 no pain and 10 the worst pain

次要结局

  • Pain Anxiety symptoms scale (PASS).(one week)
  • Number of participants with post block complication(2 hours)
  • success rate of block(one week)

研究者

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

Nevert Adel

lecturer of anesthesia

Mansoura University

研究点 (2)

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