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Clinical Trial Summary

Often the etiology of chronic pelvic pain is not clear, as there are many disorders of the reproductive tract, gastrointestinal system, urological organs, musculoskeletal system, and psych neurological system that may be associated with chronic pelvic pain. An effective treatment for this condition has evaded the medical profession for centuries. Even today only 20-25% patients respond to conservative management.5 When such treatment fails, a diagnostic laparoscopy is performed.1, 3, 6 the cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases.1


Clinical Trial Description

This prospective randomized controlled study will be conducted at Eldemerdash hospital. 60 patients will be included with the following criteria: . Intraoperatively, all patients were monitored by standard monitoring. All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (thirty patients per group): Group A ; thirty patients will do laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected. Group B; thirty patients will do laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides. Pain score ( visual analogue score) was assessed before surgery (basal) and after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1, 4, 8,12, 16,20 and 24 weeks. Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10 Duration of pelvic pain relieve after laparoscopy up to 16 weeks,side effects like urinary retention, constipation were recorded after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1week, 4weeks, 8 weeks, 12 weeks and 16 weeks. Urinary retention will be treated by reassuring the patients and catheterization as it usually resolves after 2-3 days, constipation will be treated by reassuring the patients and purgatives as it usually resolves after 2-3 days. Postoperatively, all patients were transferred to postoperative care unit (PACU) and monitored every 10 min until discharge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05345782
Study type Interventional
Source Ain Shams University
Contact RAMY mahrose, A.PROF.
Phone 01281431097
Email ramy.ahmed@med.asu.edu.eg
Status Recruiting
Phase N/A
Start date April 20, 2022
Completion date April 26, 2023