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临床试验/CTRI/2024/09/074415
CTRI/2024/09/074415尚未招募3 期

Comparative efficacy between fluoroscopy guided radiofrequency ablation of superior hypogastric plexus and radiofrequency ablation of both superior hypogastric plexus and ganglion impar in endometriosis related pelvic pain

Institue of Postgraduate Medical Education and Research, SSKM Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
VISUAL ANALOG SCALE

研究概览

简要总结

PROPOSED TOPIC OF RESEARCH:

COMPARATIVE EFFICACY BETWEEN FLUOROSCOPY GUIDED RADIOFREQUENCY ABLATION OF SUPERIOR HYPOGASTRIC PLEXUS & RADIOFREQUENCY ABLATION OF BOTH SUPERIOR HYPOGASTRIC PLEXUS AND GANGLION IMPAR IN ENDOMETRIOSIS RELATED PELVIC PAIN

OBJECTIVES OF PROPOSED RESEARCH:

To observe separate efficacy of radiofrequency ablation (RFA) of Superior Hypogastric Plexus and RFA of Superior Hypogastric Plexus with Ganglion Impar and also compare between their efficacy in endometriosis related pelvic pain.

BACKGROUND OF PROPOSED RESEARCH:

Endometriosis is one of the most common and debilitating diseases of women in reproductive age group. It constitute a great burden of different kinds of pelvic pain in women . There is significant impact of endometriosis, and particularly pain symptoms, not only on quality of life, but also on a range of activities and life domains including physical functioning, everyday activities and social life, education and work, sex, intimacy and intimate partnerships, and mental health and emotional well being. A significant number of patients, suffering from endometriosis associated pelvic pain are either non-responsive or inadequately responsive to available treatment modalities and research is ongoing to find new therapeutic options for this disease. For these patients, radiofrequency ablation of nerve plexuses carrying pain sensation from those viscera may be an effective alternative. There is scarcity of literatures on efficacy of RFA of superior hypogastric plexus as well as superior hypogastric plexus with ganglion impar in endometriotic pelvic pain reduction. So, our humble approach in this study is not only to assess the efficacy of these two procedures separately, but also compare between their efficacy in endometriotic pain reduction.

RESEARCH HYPOTHESIS:

Significant reduction of pain in terms of VAS score in Endometriosis related pain  following RFA of both Superior Hypogastric Plexus as well as Superior Hypogastric Plexus with Ganglion Impar. There will be significant difference of VAS score between these two procedures and combined approach will be more efficacious to reduce pain significantly.

METHODOLOGY:

STUDY DESIGN- Parallel group, open label, randomised controlled trial

STUDY DURATION- 18 months

PLACE OF STUDY- Department of Physical Medicine & Rehabilitation, IPGME&R and SSKM Hospital

STUDY POPULATION- Patients attending OPDs and admitted in IPDs of Department of Obstetrics & Gynaecology and Department of Physical Medicine and Rehabilitation.

SAMPLE SIZE- TOTAL 38 (19 in each group)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patient suffering from endometriosis diagnosed by Department of Obstetrics and Gynaecology with the help of imaging technique (e.g.- USG, MRI) &/or laparoscopic method &/or histology as supplement to clinical features.
  • Age of patient: above 18 years iii.
  • Patient with moderate to severe pain (VAS≥4) iv.
  • Consent of the patient for the procedure v.

排除标准

  • Abnormal coagulation profile ii.
  • Allergy or contraindications to the used medication iii.
  • Patients with local &/or systemic infections iv.
  • History of neurological or psychiatric disorder v.
  • Pregnancy vi.
  • Patients suffering from unstable cardiovascular or respiratory disorder vii.
  • Distorted local anatomy.

结局指标

主要结局

VISUAL ANALOG SCALE

时间窗: 4 weeks

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
Institue of Postgraduate Medical Education and Research, SSKM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rhitushree Biswas

Dept. of Physical Medicine and RehabilitationIPGMER, KOLKATA

研究点 (1)

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