Clinical trial NCT05345782: Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
Official title: Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Idiopathic Pain Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* • Age 18 to 50 years old.

  * American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
  * Sex: female.
  * Patients scheduled for elective laparoscopy for diagnosis of the cause of chronic pelvic pain.

Exclusion Criteria:

* • Patient refusal.

  * Patients on chronic pain medications.
  * ASA III or worse clinical condition.
  * Intra-abdominal infection.
  * Allergy to any of the study medications.

Primary outcomes:
measure: Visual analogue score
timeFrame: before laparoscopy
measure: Visual analogue score
timeFrame: 4 hours after laparoscopy
measure: Visual analogue score
timeFrame: 12 hours after laparoscopy
measure: Visual analogue score
timeFrame: 24 hours after laparoscopy
measure: Visual analogue score
timeFrame: 48 hours after laparoscopy
measure: Visual analogue score
timeFrame: 1st week after laparoscopy
measure: Visual analogue score
timeFrame: 4th week after laparoscopy
measure: Visual analogue score
timeFrame: 8th week after laparoscopy
measure: Visual analogue score
timeFrame: 12th week after laparoscopy
measure: Visual analogue score
timeFrame: 16th week after laparoscopy
Secondary outcomes:
measure: constipation(number of patients)
timeFrame: up to 16 weeks postoperatively
measure: urinary retention (number of patients)
timeFrame: up to 16 weeks postoperatively
measure: duration of pain relieve
timeFrame: up to 16 weeks postoperatively
measure: Duration of pelvic pain relieve
timeFrame: up to 16 weeks postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: asuh
name: AIN SHAMS UNIVERSITY
role: STUDY_CHAIR
References: