None listed
Conditions
Brief summary
To determine if injection of local anaesthesia into the area surrounding the pelvic nerves (superior hypogastric nerve block, or SHNB) is useful in reducing pain in patients who have undergone uterine artery embolisation (UAE). Patients will receive an injection into the retroperitoneal space (which contains the nerves supplying the pelvic organs) immediately before the UAE. It may contain either local anaesthetic or a placebo (normal saline). After the procedure the amount of pain relief needed by the patient and any associated side effects (e.g. nausea, vomiting) will be recorded throughout the patient's stay. At outpatient follow up in 6 weeks, overall satisfaction with both the UAE and the pain relief obtained will be recorded.
Interventions
Post recruitment, patients will be streamed into one of two treatment arms prior to uterine artery embolisation; superior hypogastric nerve block (SHNB) using bupivacaine 0.5% plus adrenaline at a dose rate of 0.5mg per kilogram body weight, or placebo retroperitoneal injection (normal saline).
Local anaesthetic will be infiltrated to a subumbilical site and either bupivacaine 0.5% plus adrenaline or a placebo (normal saline) will then be injected into the retroperitoneum using a 22g Chiba nee
Post recruitment, patients will be streamed into one of two treatment arms prior to uterine artery embolisation; superior hypogastric nerve block (SHNB) using bupivacaine 0.5% plus adrenaline at a dose rate of 0.5mg per kilogram body weight, or placebo retroperitoneal injection (normal saline). Local anaesthetic will be infiltrated to a subumbilical site and either bupivacaine 0.5% plus adrenaline or a placebo (normal saline) will then be injected into the retroperitoneum using a 22g Chiba needle. X-ray confirmation of the landmarks (junction of L5 and S1) will be obtained prior to injection and aspiration through the Chiba needle will be performed to confirm extravascular placement of the needle. Technical success of SHNB will be defined as spread of contrast plus local anaesthetic anterior to the vertebral body of L5.
Sponsors
Professor Ken Thomson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of symptomatic leiomyomata and referred for UAE; * Normal renal function or pre-hydration; * No allergy to contrast media or pre-treatment.
Exclusion criteria
* Viable pregnancy; * Active infection; * Known or suspected pelvic malignancy; * Previous UAE (as increased uterine ischaemia); * Contrast allergy; * Allergy/intolerance to one or more of the treatment drugs; * Allergy to cephalosporins; * History of alcoholism/Intravenous drug use; * Diagnosed hepatic disease; * Renal insufficiency; * Acute pelvic infection/ Pelvic inflammatory disease; * Endometriosis; * Adenomyosis.
Outcome results
None listed