Pain, Chronic
Conditions
Brief summary
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.
Detailed description
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.
Interventions
PROCEDURELaparoscopic Presacral Neurectomy
Laparoscopy will be performed under general anesthesia. Then, nerve plexuses will be identified and freed from their underlying tissue, which contains the left common iliac and middle sacral veins. This will be followed by cauterization and cutting of the nerve plexuses.
PROCEDUREFluoroscopically guided Superior Hypogastric Plexus Neurolysis
The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis using 3 mL of 75% ethanol and Radiofrequency of the Sacral nerve Roots 2-4.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient acceptance. * Body mass index \< 35 kg/m2. * Adult patients with chronic pelvic and perineal pain due to pelvic cancer. * Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.
Exclusion criteria
* Uncooperative patient. * Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue pain score | At the end of the first month after the procedure. | The percentage of patients who achieved \> 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily analgesic requirements | At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure. | Daily analgesic requirements at the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure. |
| Associated adverse events | At the end of the first month after the procedure. | Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAbdalla Mohamed Gouda, MD
Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
Outcome results
None listed