Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain

NCT ID: NCT03228316

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2020-12-20

Brief Summary

Cancer-related pain represents a major challenge for both clinicians and patients. This pain can be associated directly with the cancer or with certain treatments administered to the patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the current pain treatment. Pain prevalence is high in developing countries due to late diagnosis and major impediments to opioid access

Detailed Description

pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix, endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate that the prevalence of pain in patients with pelvic cancer is >50%, and can be upwards of 60% to 70% in patients with advanced or metastatic disease . Cancer patients with extension of tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only fail to provide relief, but may cause excessive sedation and other side effects. More invasive approaches may thus be needed to control pain and improve the quality of life. Since pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk between these levels. It is an extension of the aortic plexus below the aortic bifurcation, and contains almost exclusively sympathetic fibers and visceral afferents . Afferent pain fibers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami; thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer pain. Several studies examined the use of superior hypogastric plexus block in the treatment of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither the follow-up period nor the proportion with a successful prognostic block were noted. Radiofrequency utilizes a high-frequency alternating current that is passed from the needle electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to the accuracy of lesions produced by radiofrequency ablation, there has been growing interest in the use of this technique for neurolysis of nerves as it offers the potential of accurate nerve destruction ablation, with a predictable and controlled ablative lesion. Another advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and phenol, which may take up to 1 week or 10 days to achieve neurolysis .

Conditions

Chronic Pelvic Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the study group one

20 patients with superior hypogastric plexus block

Group Type: EXPERIMENTAL

superior hypogastric plexus block

Intervention Type: PROCEDURE

nerve plexus block

the study group two

20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4

Group Type: EXPERIMENTAL

superior hypogastric plexus block

Intervention Type: PROCEDURE

nerve plexus block

pulsed radiofrequency

Intervention Type: RADIATION

pulsed radiofrequency on sacral nerve roots 2,3 and 4

Interventions

superior hypogastric plexus block

nerve plexus block

Intervention Type: PROCEDURE

pulsed radiofrequency

pulsed radiofrequency on sacral nerve roots 2,3 and 4

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• sympathetically maintained pelvic, perineal pain
• pain is no longer controlled with oral morphine sustained release tablets 30 mg
• excessive sedation or other side effects from oral morphine sustained release tablets 30 mg or amitryptyline tablets 25 mg
• age between 18-70 years

Exclusion Criteria

• patient refusal
• patients with coagulopathies
• allergy to constant dyes or phenol
• patients receiving radiation or chemotherapy within 4 weeks of neurolytic block
• patients with major or moderate cardiac/respiratory incapacitating diseases
• liver and renal failure
• patients younger than 18 years and older than 70 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

marina emeel helal

principle invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Ahmed Abdel Aal, professor

Role: CONTACT

Fatmaabdelal23@yahoo.com

01113221317 ext. 002

Ashraf Amin, professor

Role: CONTACT

ashrafkena@yahoo.com

01153131503 ext. 002

References

Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.

Reference Type: BACKGROUND

PMID: 27208713 (View on PubMed)

Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.

Reference Type: DERIVED

PMID: 32214294 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

MEHG

Identifier Type: -

Identifier Source: org_study_id