An interventional study of MARCAINE AND BETAMETHAZONE 1 and MARCAINE AND BETAMETHAZONE 2 in Chronic Idiopathic Pain Syndrome, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
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.
375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 273 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Age 18 to 50 years old.
Exclusion Criteria:
Patient refusal.
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.
Drug: MARCAINE AND BETAMETHAZONE 1
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.
Drug: MARCAINE AND BETAMETHAZONE 2
Laparoscopic Hypo gastric Neural Plexus Block
Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: before laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 4 hours after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 12 hours after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 24 hours after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 48 hours after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 1st week after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 4th week after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 8th week after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 12th week after laparoscopy
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: 16th week after laparoscopy
constipation(number of patients)
Time frame: up to 16 weeks postoperatively
urinary retention (number of patients)
Time frame: up to 16 weeks postoperatively
duration of pain relieve
Time frame: up to 16 weeks postoperatively
Duration of pelvic pain relieve
Time frame: up to 16 weeks postoperatively
Plan to share: No
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Ain Shams University