Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain

Conditions
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Chronic Idiopathic Pain Syndrome

Intervention / Treatment
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* Drug: MARCAINE AND BETAMETHAZONE 1
* Drug: MARCAINE AND BETAMETHAZONE 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Hypo gastric Neural Plexus Block<br>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<br>* Laparoscopic Hypo gastric Neural Plexus Block<br>|
| Active Comparator: Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block<br>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<br>* Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score | Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10 | before laparoscopy | 
| Visual analogue score | Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 16th week after laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| constipation(number of patients) |  | up to 16 weeks postoperatively | 
| urinary retention (number of patients) |  | up to 16 weeks postoperatively | 
| duration of pain relieve |  | up to 16 weeks postoperatively | 
| Duration of pelvic pain relieve |  | up to 16 weeks postoperatively |